The Digital Hearing Healthcare or DHH Research Topic consists of 30 articles using modern digital methods to address a wide range of interesting and important hearing healthcare related issues. The interdisciplinary nature of the DHH Research Topic spans five Frontiers journals and six Frontiers sections. As the host journal, Frontiers in Digital Health published 16 articles, while Frontiers in Neuroscience, Medicine, Psychology, Public Health, and Neurology published 7, 3, 2, 1, and 1 articles, respectively. The Research Topic was initiated in March 2020, opened for submission from August 2020 to Octobor, 2021, with a total of 38 submissions being received.The World Health Organization (WHO) estimates that “more than 1.5 billion people experience some decline in their hearing capacity during their life course, of whom at least 430 million will require care,” but only a fraction of them are receiving the care, with unaddressed hearing loss resulting in an annual global cost of US$980 billion  test for smartphone hearing screening. DIN, which does not require precise sound level calibration and tests digit-triplet reception thresholds in noise, has been developed in many languages. The antiphasic DIN may be more sensitive to unilateral hearing loss and conductive hearing loss than traditional diotic DIN  is the most widely used method, resulting in a quantitative estimate of the audiogram. The audiogrm reflects the hearing threshold as a function of frequency . Wang etaccuracy , 4. ElliWillink et al. focused on the alternative pathway for hearing care by examining the HI population who do not use HAs via describing their characteristics and health care utilization patterns with the sample size of 7,361 Medicare beneficiaries. Two papers  tried to provide a deeper insight into the adoption of hearing care treatments and individual HA usage patterns by analyzing objective HA use data logged from real-world users. Braz et al. and Fontan et al. developed new fitting methods combining automatic speech recognition (ASR) to optimize compression parameters for HA. One of the most important objectives of using HAs is to improve the speech perception of HA customers, and the perception of the speech signals processed by HA technology is probably related to listeners' language experience  test using virtual sound source synthesis and found it to be a suitable alternative to more complicated and expensive setups. Sanchez-Lopez et al. developed the Better hEAring Rehabilitation (BEAR) project to measure various hearing abilities, especially supra-threshold hearing deficits.As one of the most widely-used treatments for hearing impaired (HI) listeners, hearing aids (HAs) were explored and discussed adequately in this specific issue, including more than ten papers in which HA-related research was conducted. Kang et al. used recent progress to improve noise suppression or speech enhancement of CIs and found that the intelligibility of the denoised speech can be significantly enhanced when a neural network is trained with a loss function bias toward more noise suppression than that with equal attention on noise residue and speech distortion. Vickers et al. developed a package of virtual-reality games to train spatial hearing in children and teenagers with bilateral CIs. The virtual-reality implementation demonstrated to be more engaging than traditional rehabilitation methods. As introduced in the HA section, Fletcher reviewed the effects of haptic stimulation methods on enhancing music perception in HA and CI listeners. New technologies such as advanced algorithms, virtual reality, and multimodal stimulation should be up-and-coming to positively integrate future CI devices with CI users' lives.For most patients with severe-to-profound hearing impairment, HAs cannot provide enough benefits for their speech communication. The cochlear implant (CI) is a good option for them to partially (re)gain speech perception abilities, at least in a quiet environment. However, CI users still face significant challenges in advanced hearing functions, e.g., speech-in-noise perception, spatial hearing, and music perception . Many efSearchfield et al. reviewed the first three generations of digital technologies for tinnitus management, ranging from digital hearing aids and apps to stand-alone, customized digital devices. Most interestingly, they forecast the fourth-generation digital technology that incorporates physiological sensors, multi-modal transducers, and AI for personalized tinnitus therapy.Tinnitus, or ringing in the ears, affects 15% of the general population. At present, tinnitus mechanisms remain unclear . AlthougD'Onofrio and Zeng examined technological and regulatory barriers for a wide range of audiological services from audiometry to hearing device fitting and rehabilitation. Most of these barriers can be overcome not only to provide reliable and effective tele-audiological service, but more importantly, to improve access to care, increase follow-up rates, and reduce travel time and costs. Luengen et al. envisioned an innovative tele-audiological model that consists of (1) one-to-one remote interaction between a patient and an audiologist, (2) a one-to-many model that relies on automated service provided by AI, and (3) a several-to-many application that can fit hearing devices not only based on the patient's audiological profile but also their listening environments. One critical piece of information in tele-audiology is reliable monitoring of hearing status and device functionality, especially for a complicated device such as a CI. Parreño et al. developed a self-monitoring method of measuring CI electrode impedance. Making use of a computer, the device interface provided by the manufacturer, and secure internet connectivity, they were able to record, transfer and monitor impedance at home without any adverse events. Another critical piece of information is accurate and reliable communication between the patient and providers in tele-audiology. Zendel et al. found that current teleconferencing is less reliable than in-person instruction in terms of patients' recollection of the healthcare messages delivered. Speech and video quality, as well as communication methods, need to be improved in order to reduce the memory deficit associated with current telehealth technologies.Accelerated by COVID-19, tele-audiology has become a necessary means of delivering hearing care service, especially for the most-vulnerable elderly population. Wang et al. followed a similar approach, analyzing over 10,000 audiograms for notch appearance, identifying three noise-induced hearing loss subtypes in the process. Using a different type of data, Chen C. et al. employed a recurrent neural network and signal processing to recognize potential waveforms in Auditory Brainstem Response (ABR) signals. Big Data can be leveraged in different ways, as well. For example, Cox and de Vries learned from existing databases how to shorten the test time of future audiograms computed in real time using an ML algorithm.Machine Learning (ML) represents a set of tools that reveal complex trends in data that would be difficult or impossible to discern otherwise. Often these tools are powered by large amounts of data (“big data”), which provide more opportunities to observe interesting trends. Ellis and Souza took this approach to train an ML classifier of audiograms using almost 10,000 individuals from a large national auditory and demographic information database. Christensen et al. clustered the usage activity of 64 hearing aid users over several days with a straightforward K-means algorithm. Pasta et al. approached a similar problem with nearly 16,000 users and several month's worth of data. They used a more sophisticated multilayer neural network to reveal finer trends.Ongoing data collection enabled by always-connected devices offers the opportunity to trade up for more informative algorithms as more data become available. Kang et al. describe a deep learning  approach to improve speech enhancement in cochlear implant (CI) encoding algorithms. Braz et al. used knowledge of audiograms and a genetic algorithm to search the many configurations of hearing aid program settings to optimize the device for a particular patient.ML methods have great potential for therapeutics as well as diagnostics. Fletcher contributed a review paper to discuss “Can haptic stimulation enhance music perception in HI listeners.” It has been reported that “electro-haptic stimulation” improves melody recognition and pitch discrimination, as well as speech-in-noise performance and sound localization. This review paper focused on the use of haptic stimulation to enhance music perception in HI listeners. One of his conclusions is that haptic devices, in concert with other modalities, can enhance the music experience in hearing impaired listeners. Using several sensor technologies, modern HAs strive to become better, more personalized, and self-adaptive devices that can handle environmental changes and cope with the day-to-day fitness of the users. Skoglund et al. measured the accuracy of activity tracking, e.g., step detection, through small accelerometers embedded in hearing aids. They showed classification of activities was similar to conventional activity tracking techniques, which is encouraging for applications in hearing health care. In noisy conditions, small microphones can be employed to improve the signal-to-noise ratio. Chen J. et al. confirmed that wireless microphones improve speech recognition in Chinese hearing impaired listeners when the target speaker is at a larger distance.Miniaturization has led to smaller sensors and stimulators to create haptic devices worn as gloves or bracelets. Pragt et al. examined the speech recognition performance of four ASR apps on smartphone using conventional Dutch audiological speech tests. They compared human speech recognition performance and performance by ASR apps. They found that the performance of the apps was limited on audiological tests that provide little linguistic context or use low signal-to-noise levels. They concluded that conventional performance metrics and conventional hearing tests are insufficient to assess the benefits of ASR apps for the deaf and proposed that adding new performance metrics including the semantic difference as a function of SNR and reverberation time could help monitor ASR performance. Another strategy uses ASR, hearing loss models, and hearing aid signal processing simulations to mimic impaired hearing listeners. As mentioned in the Hearing Aid section, Braz et al. and Fontan et al. demonstrated that ASR, in combination with random search algorithms, can be used to find optimal subsets of parameter settings for hearing aids. These optimizations should subsequently be validated in actual hearing aid users, especially in case of severe hearing loss. Recently, ASR has also been used in predicting CI performance , Better hEAring Rehabilitation (BEAR) to provide a test battery for hearing loss characterization , User-Operated Audiometry (UAud) to introduce an automated system for user-operated audiometric testing into everyday clinical practice , BEARS (Both EARS) to develop virtual reality training suite for improving spatial hearing for 8–16 year-olds with bilateral CIs , OPRA for developing Objective Prescription Rule based on ASR . These long-term, collaborative projects may result in improved efficiency while lowering the cost for hearing healthcare.It is worth noting that several articles present the progress of their projects driven by long-term interdisciplinary collaborations. They are SHOEBOX Audiometry for hearing screening using sound-attenuating headphones (http://www.itap.org.cn/) was founded in 2017 in China and has a vast interest overlap with this DHH Research Topic. Computational audiology, the application of complex models to clinical care , which have provided a platform to share progress in e-research, machine learning, big data, models, virtual reality, and other developments. The Research Topic, iTAP, and VCCA all share the same goal of providing a platform for facilitating communication between experts from different fields and accelerating research and development.The interdisciplinary nature of the DHH field also provides great challenges and opportunities for both academic research and industrial development. For example, the Interdisciplinary Technologies for Auditory Prostheses (iTAP) conference series , Science and Technology Program of Guangzhou (202102020944). JC was supported by the National Key Research and Development Program of China (2021ZD0201503) and National Natural Science Foundation of China (12074012). CZ was supported by National Natural Science Foundation of China (31900801). DB was supported by the Advanced Education Research & Development Fund and the National Institues of Health (R21EY033553). F-GZ was supported by the National Institues of Health (5R01DC015587 and 1R01AG067073).DB reports equity ownership in Bonauria. F-GZ reports equity ownership in Axonics, DiaNavi, Neocortix, Nurotron, Syntiant, Velox and Xense. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


The present study aimed to evaluate the effects of the Active Communication Education (ACE) program on the social/emotional impacts of hearing loss (HL) in a group of older adults with a cochlear implant (CI).Prospective cohort study design, with a “within-subject” control procedure.Twenty adults over-65 post-lingually deafened CI users. All subjects were required to be native Italian speakers, to have normal cognitive level, have no significant psychiatric conditions and/or diagnosed incident dementia, and used CI for at least 9 months.Twenty participants were assessed using the Hearing Handicap Inventory for the Elderly (HHIE), the Geriatric Depression Scale (GDS), and the Speech, Spatial, and Qualities of Hearing Scale (SSQ) before, during, and after ACE program, with a one and 6-month follow up. The cognitive and audiological evaluation was carried out before commencing the ACE program.The ACE program had a positive impact by reducing HL’s social/emotional effects. Participants benefited from a rehabilitative approach by improving multilevel skills: comprehension of audiological and hearing dimensions, acquisition of communicative, pragmatic and problem-solving strategies, and interaction and sharing of experiences with peers.Although targeting the older adults with moderate HL, the ACE program also seemed to benefit older adult CI users. An improvement in social and emotional adaptation to hearing difficulties can, in turn, significantly promote optimal use of CI in the older adults, thereby possibly reducing the risk of losing motivation and engagement in device use and in rehabilitation protocols. Age-related hearing loss (HL) is the third most frequent chronic disease in the older adult population, immediately after cardiovascular disease and arthritis, affecting more than 40% of the population over 65 years of age . ARHL deself-efficacy); social dimension , behavioral dimension (limitation/reduction in activities), and physical dimension .Furthermore, when HL occurs later in life, it can possibly coincide with other age-related health problems. Hearing impairment adds to an already compromised functional framework, further negatively affecting sense of independence and autonomy. It can cause everyday restrictions in social participation, feelings of sadness, isolation, helplessness, incompetence, and depression. HL in the older adults may significantly diminish psychological functioning and social interactions , increasIn severe/profound HL cases, when the benefits derived from hearing aids are poor or absent, a cochlear implant (CI) provides the most suitable solution. CI is a sensory neuro-prosthetic device representing the “gold standard” in the treatment of deafness. It works through electrical neuronal stimulation capable of imitating the natural physiology of sensory organs. It offers an auditory threshold in the free field of 20–35 dB for frequencies from 250 to 8,000 Hz and provides an excellent understanding of speech in acoustically quiet environments. When CI is activated, it generates an electrical response, targeting spiral ganglion, and auditory nerve fibers, bypassing the organ of Corti. The brain interprets the artificial electrical stimulation of CI as an auditory sensory input innervating the receptor cells.Although there is significant variability in CI outcomes in older people—greater than in younger age groups , the oldOver recent years the adoption of the modern International Classification of Functioning, Disability and Health (ICF) approach  has led Additionally, research into treating severe-profound deafness in adults and older adults has increasingly highlighted that hearing impairment in old age needs to be tackled beyond aural rehabilitation through hearing aids and/or CI alone . The necActive Communication Education (ACE) is a rehabilitation program focusing on the quality of life and psychological status of older people with hearing impairments developed through a research program at the University of Queensland .The original version of ACE was a program of five weekly sessions created to help adults with HL (hearing aid users and non-users) become more effective communicators in order to improve their quality of life. The ACE handbook defines it as a problem-solving interactive program “to help adults with hearing loss to become more effective communicators and to provide them with strategies to cope with everyday difficulties” , p. V.Studies exploring the effectiveness of ACE in older persons with mild-moderate HL with and without hearing aids demonstrated the ACE program to be effective in reducing communication difficulties . The sucNevertheless, all these studies investigated the effectiveness of ACE at reducing communication difficulties and hearing handicaps in subjects with a mild or moderate hearing impairment, indifferently using or not using hearing aids. None of these studies investigated the effectiveness of an ACE program on profoundly deaf older adults with CI.The aims of the present study were:(i)Firstly, to investigate the effects of the ACE program  on older(ii)The secondary outcomes were to explore, if present, any changes in perceived auditory disability and in depressive symptomatology, and to investigate the influence of audiological and personal variables of the intervention outcome.The preliminary steps in the present project were to translate and adapt into Italian the Active Communication Education (ACE) program  designedTo translate and adapt ACE into Italian and be cognizant of Italian culture, we followed the guidelines recommended by (i)Initially, we researched the literature to establish if an Italian translation of the ACE program already existed: two authors (IG and PM) searched independently and no Italian translation was found.(ii)Three authors , who have broad experience with CI users, set out the key objectives to be followed and customized for the end-users. To achieve this, each of the three authors prepared a list of characteristics for the target population (older adult CI users) from cultural, linguistic, and audiological points of view.(iii)Three of the authors  independently translated the entire ACE program (handbook and handouts). Italian is the mother tongue for all three. All of them are health care professionals with wide experience in the management and rehabilitation of hard-of-hearing older patients . Moreover, one of the authors (PM) has a certified proficiency linguistic competency, and the other two (IG and MN) have excellent proficiency in English.(iv)The obtained three draft translations were compared, discrepancies were reviewed and harmonized, and one single translation/adaptation was finally created. A further comparison of the translated document with the original was undertaken by an author of the study (BI) who was not involved in the draft translation process. No significant discrepancies were found, and the translation process was completed.(v)In order to meet the characteristics and needs of the target population  some linguistic, cultural, and structural modifications were required. After the translation and the reported changes were completed, the Italian ACE version for CI older adult users was delivered through seven fortnightly group sessions lasting about 2 h each and for up to six-eight participants. A psychologist, a speech-therapist, and an audiologist, all with a significant experience in the management and care of HL, conducted the group sessions.The aims of each session were the same as the original ACE program : expressThe expression of communication needs’ outcome was delivered during the first two modules, which focused on introducing the program and identifying participants’ personal and specific communication needs or difficulties in their daily use of CI. The needs and communication requirements identified during these first two sessions determined the subsequent priorities for addressing these issues. Each session topic was selected, starting with the participants’ communication needs deemed as most important.Regarding the “awareness of communication obstacles” outcome, there was a detailed discussion on the possible causes of the expressed participant communication difficulties and their possible solutions. Participants’ awareness was developed by performing practical activities during the session or by giving each participant the relevant information to perform these at home.Participants were encouraged to use the problem-solving and communication strategies practiced during each session in a wide range of communicative challenging situations.Metacognitive control can be defined as the ability to self-evaluate the accuracy and adequacy of one’s performance during mental or operational tasks. It includes self-instruction skills, i.e., being conscious of when, how, and why to flexibly apply one strategy or another when trying to reach one’s goals. It also includes awareness of the resources available and their limitations, personal strengths, and weaknesses . To empoFinally, in each session, the presence of family members and/or significant others was highly encouraged and, when present, they were actively engaged in the sessions.Participants were recruited from the Cochlear Implant Center, Department of Sense Organs, La Sapienza University of Rome. The study was approved by the Policlinico Umberto I Ethical Committee .Inclusion criteria for the study were: age at the time of study being 65 years or over; use of unilateral (CI), bilateral (CI/CI) or bimodal (CI/HA) cochlear implants; duration of CI use > 18 months; absence of malformations of the inner ear, ossification/fibrosis of the cochlea and/or incomplete insertions of the array; no significant self-reported history of psychiatric conditions and/or diagnosed incident dementia; average cognitive level . All unilaterally and bilaterally implanted participants presented with bilateral severe-profound HL. Bimodal users showed severe/profound HL on the implanted side and a downsloping moderate-severe HL on the HA side.During the program, four subjects were excluded from the study because they did not attend sufficient sessions to be included in the analysis. More specifically, two subjects have attended only 30% of the sessions because of serious illness of a family member; one gave up after two sessions because of cholesteatoma on the implanted ear, and one due to fracture of the femur. Therefore, the final number of participants who completed the protocol was 20 (9 men and 11 women), with a mean age of 72.05 years  and the mean time of CI use was 5 years . All participants received 6 months of auditory training soon after CI activation, as is our Cochlear Implant Center practice. The subjects’ Free Field (FF) threshold mean value was 28.3 (SD 1.8) dB HL from 250 to 4,000 Hz.Fourteen of the subjects were married; four were widows and two were unmarried. Of those unmarried and widows, four lived alone and two lived with siblings. All subjects were implanted by two expert surgeons using a traditional implant, with a receiver housed posteriorly to the mastoid, mastoidectomy and posterior tympanotomy, and cochleostomy at the antero-superior margin of the round window. Five participants (25%) were unilateral CI users, four (20%) bilateral and 11 (55%) bimodal (CI/HA). The mean age at cochlear implantation was 67.7 years  + 10. The speech material was highly redundant, the primary signal presented at 0° from the participant’s head at 65 dB HL. The results are reported in% correct score but were further converted into Rationalized Arcsine Units (RAU), used to transform data obtained from speech intelligibility tests to make them suitable for parametric statistical analyses . RAU scoThe It-Matrix was based on an adaptive SNR paradigm and measured the speech reception threshold (SRT), where 50% of sentences were repeated correctly. Because of the semantically unpredictable structure, the lists cannot be memorized easily and thus, can be used repeatedly. Participants were advised to ask for a break whenever they needed one to avoid performance deterioration due to excessive strain. A training scheme was created for each test and provided to all participants before undertaking the test. The outcomes for free speech perception in quiet and in noise for the study group are reported in Participants’ quality of life, in terms of the social and emotional impact of HL on daily lives, was assessed at baseline, prior to the start of the ACE program (T0), within 1 month of the end of training (T1), and 6 months afterward (T2)   was usedSSQ is a self-reporting questionnaire designed to measure a variety of hearing disabilities in a range of different contexts and realistic communication scenarios.SSQ is an intermediate link between the audiological measurement of someone’s HL and a patient’s self-assessment of how HL impacts their wider life . Particular attention is given to the competitive, spatial, and movement components of spatial hearing and the real auditory world’s three-dimensional and temporally dynamic aspects. SSQ was developed assuming that hearing is “scenic analysis”: sound always occurs around us virtually, emanating from different sources and at several times. When a sound is salient, the listener shifts attention, with eyes and head toward the source. One listens carefully; thus, one comprehends sound and can engage in communication and effective dialogue. SSQ consists of three sections:–Section one (Speech): 14 items on speech hearing. Items covered include several speech hearing situations: the condition of competing sounds, visibility of talkers, number of persons included in the conversation, and different background conditions.–Section two : 17 items on spatial hearing: items covered include directional and distance judgments and discrimination of movement.–Section three :18 items on other hearing qualities: items included ease of listening, naturalness, clarity, and identifiability of different speakers, signal segregation, identification/recognition of different musical pieces and instruments, and different everyday sounds.The questionnaire is best administered in the form of an interview , and parAs for secondary outcome measures, the Geriatric Depression Scale (GDS)  was usedAnalyses were conducted using non-parametric statistics: Wilcoxon signed-rank test (pre-program vs. 1-month post-program vs. 6-months post-program). Bonferroni correction was used to account for the within-group comparisons. Within-group changes and effect sizes   were calHHIE subscales and total scores were analyzed. Concerning the Emotional Subscale of HHIE (HHIE-E), at T0, 11 subjects (55% of participants) had a significant emotional maladjustment to HL, six subjects (30%) showed a mild-moderate maladjustment, and three subjects (15%) revealed a decent emotional adjustment to HL.At T1 and in the 6-month follow-up (T2), 11 subjects (55% of participants) showed mild-moderate emotional maladjustment, six subjects (30% of participants) revealed no hearing-related emotional problems and only three subjects (15% of participants) still had severe emotional impairment.Concerning the Social Subscale of HHIE (HHIE-S), at baseline (T0), 14 subjects (70% of participants) showed significant social maladjustment concerning their hearing impairment, five subjects (25% of participants) revealed a mild-moderate social suffering and only one subject (5%) had no hearing-related social problems.At the within T1 assessment, the percentage of subjects with severe social issues dropped to 25% (5 participants), 12 subjects (60% of participants) had a mild-moderate social maladjustment, and three subjects (15% of participants) reported no hearing handicap or social suffering.At T2, the percentage of participants with severe social problems was unchanged from T1 , 10 subjects (50%) had a mild-moderate hearing or social hearing handicap, and five subjects (25%) reported no hearing handicap or social suffering.SD 23.5) for the Emotional Subscale (corresponding to significant handicap); 52.9 (SD 19.6) for the Social Subscale (corresponding to significant handicap) and 49.1 (SD 20.3) for Total Score (corresponding to significant handicap). At T1, the study group obtained a mean HHIE score of 26.0 (SD 16.2) for the Emotional Subscale (corresponding to mild-moderate handicap); 32.7 (SD 14.5) for the Social Subscale (mild-moderate handicap) and 29.6 (SD 14.4) for Total Subscale (mild-moderate handicap). For each subscale, score differences between T0-T1 were > 12 points.At baseline, the observed mean scores for HHIE were: 45.5 (SD 16.3); for Social Subscale 32.7 (SD 17.9), for Total Subscale 27.4 (SD 16.19). Differences T1-T2 were < 12 points, denoting stability of outcomes.At T2 mean scores were: for Emotional Subscale 23.4 (p < 0.05), therefore, non-parametric statistics were used to explore the questionnaire results.HHIE scores were not normally distributed  and in T0-T2 comparison . No statistical differences were found in T1-T2 evaluations .Wilcoxon signed-rank test for within-group comparisons (pre-program vs. 1-month post-program vs. 6-month post-program) showed statistically significant differences. In Emotional Subscale differences were found between measures at T0 and T1  and between T0 and T2 ; as for the Emotional Scale, no statistically significant differences were found in T1-T2 comparison .In Social Subscale, significant differences were found between T0 and T1 , in T0-T2 comparison  and slightly in T1-T2 .In Total Scale significant differences were found in T0-T1 comparison , for Social (0.81) and for Total Subscale (0.79) ,B.p < 0.001, effect size = 0.87; Spatial (SSQ_Spa) p < 0.001, effect size = 0.88; Qualities (SSQ_Q) p < 0.001, effect size = 0.88. The scores even improve at T2 for the Speech scale  and the Qualities scale   . SSQ_T fZ = 2.93, p = 0.003) and between T0 and T2  with a medium effect size .Concerning depressive symptomatology assessed using GDS, at baseline, nine subjects (45% of participants) had mild-moderate depressive symptoms, six subjects (30% of participants) had no depressive symptoms, and five subjects (25% of participants) presented significant depressive symptoms. At T1, 15 participants (75%) showed no presence of depressive symptoms, four (20%) had mild-moderate symptomatology and one participant still had significant depressive symptoms (5%). At T2, 13 participants (65%) showed no depressive symptoms, and seven (35%) had a mild-moderate depressive symptomatology. None of the participants showed any significant depressive symptoms. Wilcoxon signed-rank test for within-group comparisons showed statistically significant differences between measures at T0 and T1 , except for a significant relationship between GDS and HHIE-Emotional and Total Subscale at T0 (p < 0.05).Regarding personal variables , no significant relationships were found at any time point , the correlation coefficients are reported in The main aim of the present study was to explore the effectiveness of the ACE program  when conACE is a rehabilitation program developed to improve the communication and quality of life of older people with hearing impairments. The empirical evidence to support the effectiveness of the ACE program on older community-based adults with mild-moderate hearing impairment was first studied by SD 23.5) to 26.0 (SD 16.2) for the Emotional subscale and from 52.9 (SD 19.6) to 32.7 (SD 14.5) for the Social Subscale. In the T0-T1 comparison a reduction superior to 12 points was recorded for each subscale –that is the minimum score differential indicated by Consistent with the above-cited studies, results from the present investigation indicate how the ACE program can also be used with severe/profoundly deaf older adult CI users, improving their level of hearing-related socio-emotional adaptation. HHIE subscales showed that the majority of them had at baseline severe emotional and social maladjustments , and that after the end of the program, that number had dropped significantly . These changes were reflected in a significant reduction in the mean scores that went from 45.5 . Constant contact with professionals may have helped maintain their motivation to continue implementing the strategies learned and allow for only a minor decay in the memory trace. However, at the end of the program, the participants were not reminded to use the strategies or to do the exercises learned in the program; the study subjects received equal treatment as the others referred to the CI Center, following a multidisciplinary approach for all patients.The secondary outcomes of the present study were to explore any change in depressive scores and in perceived auditory disability both at the end of the ACE program and at the 6 month follow-ups and investigate the influence of audiological and personal variables on the outcome of the intervention.Concerning depressive status, GDS scores revealed a significant reduction in depressive scores from T0 to T1 and T2: it is noteworthy that the percentage of participants with mild-moderate and significant depressive symptoms, taken together, was at 80% at baseline, dropping to 20% in the 6-month follow up. These results seem consistent with It can also be assumed that, for ACE participants, the opportunity to take advantage of an environment where they could express, compare and share their personal experiences and feelings may have been helpful to them, with the effect of both decreasing distress related to hearing impairment and on depressive symptomatology . ParticuWith respect to perceived auditory disabilities, the participants’ scores in the SSQ questionnaire increased significantly during the post-training assessment, showing an improved self-perception of their auditory function in everyday life listening experiences. Overall, the improvement in SSQ-Total score observed in the present study group was clinically relevant, as shown in a prospective clinical study conducted on older adults subjects with CI . Soon afA significant improvement, backed up by a medium effect size, was found in depressive symptomatology between pre-treatment and post-treatment GDS scores, which were maintained at 6-month follow-up. Also, a correlation was found between the depressive symptomatology at baseline and the emotional domain of hearing-related quality of life. This correlation can be explained by published research on this topic  that fouOther variables that could have influenced outcomes measured in the present study were chronological age, gender, level of education, duration of HL, duration of CI use, and speech perception abilities in quiet and noise.N = 77) with a complete range of HL (from mild to profound) with an age range from 41 to 94 years, of which 14% were aged < 65 years and 86% aged > 65 years. Moreover, as highlighted by No significant differences in social/emotional impacts of HL on HHIE outcomes were identified concerning age and gender neither at baseline nor in post-program evaluations. With regard to the effect of age, the present findings appear consistent with the work of The only factor showing a significant correlation with the Emotional subscale of HHIE, measured soon after the end of the ACE program, was the baseline words recognition score in quiet.The lack of correlation is likely to be multifactorial, as many factors can influence both hearing performance and quality of life. Effectively, self-assessed hearing handicaps cannot be reduced solely to speech perception-related HL, as HHIE measures typically reflect the self-assessment of handicap across many prior daily life experiences rather than the self-assessment of handicap during or immediately after a speech recognition task.A further explanation for the lack of correlation is the variability of speech perception ability, ranging from very poor to average for a CI user, and, given the small study group, this may have conditioned statistical analysis. All subjects involved in the study were able to complete the speech perception test in quiet, with scores ranging from 0 to 100%, while up to 30% of subjects could not complete the test in noise, which was particularly evident for the Matrix sentence test. In this respect, the Matrix test is semantically more complex when compared to everyday semantically predictable sentences , which mFurthermore, outcomes in auditory perception have been shown to be poorer in the older adults when compared to younger individuals, as HL and aging reduce central and peripheral binaural processing, which partially accounts for the difficulties that such subjects experience in complex listening situations .Similar to our findings, an absence of or modest association between auditory perception tasks and HHIE subscales was also reported for pure-tone thresholds , word reDifferences in findings with the above study should also be read in the light of the specific composition of our study group which was composed of profoundly deaf cochlear implantees. Therefore, it was characterized by additional listening difficulties related to a device that is more limited in frequency resolution and loudness growth when compared to natural hearing . EffectiTo our knowledge, no other research has been published concerning the correlation between HHIE and speech perception tests using adaptive noise paradigms in CI users.In conclusion, considering the challenging experiences that older adult CI users encounter in everyday communication, the outcomes from the present study and the literature underline the need for rehabilitative programs approaching both audiological and extra-audiological variables. These should include multilevel skills such as comprehension of audiological and hearing dimensions, acquisition of communicative, pragmatic, and problem-solving strategies, implementation of interaction, and sharing experiences with peers. As the number of subjects attending the program increases, this will most likely help in shedding more light on further variables influencing self-perceived disability and further improve the implementation of rehabilitation protocols aimed at promoting optimal use of CI, with high levels of motivation and perceived benefits in the older adult population with HL.The main limitation of this study was the absence of a control group. The decision not to include a control group was related to statistical/demographical issues concerning the large intrasubject variabilities found in CI users  which diAnother potential limitation concerns the tool selected to measure the primary outcome of the present study. HHIE was selected because it is one of the most commonly used questionnaires for assessing hearing-related perceived handicaps and the psychosocial effects of audiological rehabilitation programs . ConsequThe present study represents the first attempt to evaluate the benefits of the ACE program for older adults CI users. Results are promising as they show a significant decrease in self-perception of emotional and situational distress, an improvement in depressive symptomatology and a reduction in self-perceived auditory disability. The increased awareness of the predictability of some challenging social situations can result in decreased anxiety, insecurity, and social tension  and bettFurther studies, designed to overcome the limitations of the present study and incremental to the degree of evidence in the present findings would be desirable in future research.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by Policlinico Umberto I Prot. 259/2020. The patients/participants provided their written informed consent to participate in this study.All authors contributed to the conception, design of the study, data collection, interpretation of results, and approval of the final version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Behavioral measures, such as pure-tone audiometry (PTA), are commonly used to determine hearing thresholds, however, PTA does not always provide reliable hearing information in difficult to test individuals. Therefore, objective measures of hearing sensitivity that require little-to-no active participation from an individual are needed to facilitate the detection and treatment of hearing loss in difficult to test people. Investigation of the reliability of the auditory steady-state response (ASSR) for measuring hearing thresholds in older adults is limited. This study aimed to investigate if ASSR can be a reliable, objective measure of frequency specific hearing thresholds in older adults. Hearing thresholds were tested at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz in 50 participants aged between 60 and 85 years old, using automated PTA and ASSR. Hearing thresholds obtained from PTA and ASSR were found to be significantly correlated (p < .001) in a cohort consisting of participants with normal hearing or mild hearing loss. ASSR thresholds were significantly higher as compared to PTA thresholds, but for the majority of cases the difference remained within the clinically acceptable range (15 dB). This study provides some evidence to suggest that ASSR can be a valuable tool for estimating objective frequency-specific hearing thresholds in older adults and indicate that ASSR could be useful in creating hearing treatment plans for older adults who are unable to complete behavioral PTA. Further research on older adults is required to improve the methodological features of ASSR to increase consistency and reliability, as well as minimize some of the limitations associated with this technique. Sensory processing declines across adulthood, with one third of those over the age of 65 being affected by disabling hearing loss (HL) . It is eAssessing auditory acuity is frequently obtained using pure-tone audiometry (PTA), the gold standard for evaluating hearing threshold status, however, PTA does not always provide reliable hearing information in difficult to test individuals . This caThe auditory brainstem response (ABR), a far-field auditory electrophysiological test conducted using surface electrodes, provides an objective alternative method for measuring hearing function and is used particularly in infants and children not suited for behavioral PTA. ABR includes auditory evoked potentials from the eighth cranial nerve (auditory nerve) and neurons along the brainstem auditory pathway after presentation of an acoustic stimulus . ABR evoHowever, a major limitation of the click-evoked ABR for assessing hearing sensitivity is its inability to determine frequency-specific hearing thresholds . As clicTone-evoked (tone-burst) ABR can be used to assess responses in one ear to one frequency at a time, however, this is time consuming and, like click-evoked ABR, does not provide responses in cases of severe and profound hearing loss . RecentlAuditory steady-state responses (ASSR) has been suggested to be another objective audiometry test that can overcome some of the limitations associated with ABR . SimilarASSR can be used to evaluate hearing sensitivity at a range of frequencies similar to behavioral PTA, using simultaneous stimulation and evaluation of multiple frequencies binaurally . ASSR rePrevious research suggests that ASSR can be a reliable predictor of hearing thresholds when compared to PTA in both children and adults , 35–37. Community-dwelling  older adults (aged 60 years and over) were recruited from an ongoing longitudinal research project known as the Western Australia Memory Study (WAMS). All procedures undertaken in this study were conducted in accordance with ethical approval (HPH-139) from the Ramsay Health Care WA| SA Human Research Ethics Committee . As part of the WAMS, participants underwent comprehensive neuropsychological assessments, using self-reports and informant-reports questionnaires and surveys. All participants completed a demographic questionnaire and provided informed consent. Participants with current or previous diagnosis of a neurodegenerative disease, stroke or psychotic disorders were excluded from this study. Only older adults who performed within the normal range on cognitive measures were included in this study. More information on the neuropsychological and psychological assessments used in the WAMS can be found in Sohrabi et al. . ParticiPure tone audiometry was conducted (air-conduction) bilaterally at 500, 1000, 2000, 4000, 8000 Hz using the KUDUwave 5000 system, Type 2 clinical audiometer . Tones were presented via insert earphones which were inserted in the ear canals with circumaural headphones placed over the ears. An automated threshold-seeking paradigm was used to establish hearing threshold. At each frequency, threshold levels were determined using the Hughson-Westlake  procedurASSR was performed in an electrically shielded and sound attenuated room. Participants were tested while awake and in a relaxed Fowler's position . Air-conASSR recordings were obtained using four Ag/AgCl disc electrodes which were placed according to the International Electrode System (IES) 10-20; two inverting (reference) electrodes on each mastoid (one behind left ear and one behind right ear) behind the ear, non-inverting (active/recording) electrode at vertex (Cz) and ground electrode on the lower forehead. Prior to recording, the skin was prepared for electrode placement with a mild abrasive to obtain electrode impedances under 5 KΩ. ASSR measurements were performed using a descending procedure, by recording electrical responses while reducing the intensity of the acoustic signal in 10 dB steps until the threshold. The threshold was defined as the minimum intensity of detected responses, with a maximum of 7 min search time for each frequency allowed. Participants were not required to actively participate during ASSR recordings. Default correction factors  on the Chartr EP system were applied to all final audiograms obtained from ASSR. To minimize artifacts and noise interference as a result of body movement, participants were instructed to stay still during the recording.t-test was used to compare normally distributed continuous variables between PTA and ASSR measures. PTA and ASSR threshold measures were also compared with an assessment of the correlation using Pearson's correlation analysis. Frequencies in which ASSR testing did not elicit a response were excluded from the final statistical analysis. A p-value of < 0.05 was considered statistically significant.After the PTA and ASSR measurements, statistical analysis was performed using IBM SPSS Statistics, version 25.0 . Continuous variables were presented as a mean with standard deviation, and categorical variables were presented as absolute numbers and percentages. A Student A total of 50 (100 ears) community-dwelling older adults  took part in this study . Particin = 14) had significantly higher hearing thresholds (p < 0.05) when compared to females , t(48) = 3.26; p = 0.002. There was a low, however significant, correlation between PTA thresholds and participant age, r(49) = 0.28; p < 0.05, showing increased thresholds with age.Behavioral hearing thresholds using PTA were obtained for the whole sample. In this study, hearing range between 0–25 dB HL was considered normal hearing, 26–40 dB HL was considered mild HL, 41–55 dB HL was considered moderate HL, 56–70 dB HL was moderately severe HL, 71–90 was considered severe HL and 91 dB HL and above was considered profound HL. According to average 4-point PTA threshold measures, 78% (39/50) of participants had normal hearing thresholds (0–25 dB HL) and 22% (11/50) had mild hearing loss (26–40 dB HL). There was no significant correlation between PTA threshold measures and participants' depression, anxiety, or stress scores (Pearson's correlation). On average, males  = 0.48; p < 0.05.ASSR thresholds could not be measured in 34%, 10%, 1% and 27% of ears for 500, 1000, 2000, and 4000 Hz frequencies, respectively. These cases were excluded from further statistical analysis for the frequency in which no response was measured; hence the number of data points differs between frequencies. ASSR testing took on average 20 min to complete, with the shortest time recorded to achieve threshold measures at all tested carrier frequencies being 3.5 min and the longest time being 30.5 min. Threshold measures for all four carrier frequencies were obtained in 36% (18/50) of participants. Of those participants the average 4-point hearing thresholds indicate 72.2% (13/18) had normal hearing, 22.2% (4/18) had mild hearing loss and 5.5% (1/18) had moderate hearing loss. There was no significant correlation between ASSR thresholds and participants' gender, depression, anxiety, and stress scores (Pearson's correlation). There was a moderate, and significant, linear positive correlation between ASSR thresholds and participant age t-test analyses. The significant difference between the two procedures  was seen at all frequencies, 500 Hz  = 5.49; p < 0.001), 1000 Hz  = 5.58; p < 0.001), 2000 Hz  = 6.87; p < 0.001) and 4000 Hz  = 4.28; p < 0.001), in order from highest to lowest threshold difference  PTA thresholds, 18% underestimated PTA thresholds and 23% were the same as the PTA thresholds. A similar trend can be seen when looking at each carrier frequency separately, with the majority of ASSR thresholds overestimating the PTA threshold . Over 80p < 0.001) linear correlations between hearing threshold measures from ASSR and PTA at 1000 Hz, 2000 Hz and 4000 Hz at r(89) = 0.53, r(98) = 0.74, and r(70) = 0.84, respectively. A moderate, yet significant, correlation between thresholds for ASSR and PTA was seen for the 500 Hz carrier frequency (r(65) = 0.42; p < 0.001). Similarly, correlation analysis of each ear separately resulted in strong correlations for threshold measures between ASSR and PTA at 1000 Hz (right ear only), 2000 Hz and 4000 Hz and moderate correlations at 500 Hz and 1000 Hz (left ear only). See Correlation analysis, as presented in Hearing thresholds obtained from PTA and ASSR in the current study were found to be significantly correlated in a cohort consisting of elderly participants with normal hearing or mild hearing loss. This is in agreement with other studies that also reported a significant correlation between hearing thresholds obtained using PTA and ASSR , 37, 48.In most cases, ASSR over estimated PTA thresholds. Over estimation of hearing thresholds could lead to an increased risk of false positives  as well as over estimation of HL severity. Variations in the analysis algorithm and application of correction factors used to obtain ASSR and PTA thresholds could be contributing factors to the variation in threshold measures between the two techniques . In commOne factor that may influence the observed variations is the modulation rate used. In this study, for ASSR, default modulation rates were set for each carrier frequency according to manufacturer [Chartr EP ] recommeAdditionally, phase-locking of ASSR is suggested to be lower at high modulation rates in middle-aged and older adults in comparison to young adults . This han = 50). Similarly, a study conducted on children (n = 20) found that ASSR thresholds were obtained for all frequencies tested  in only 45% of the sample  hearing thresholds in frequencies between 1000 and 4000 Hz and more than 10 dB difference for 500 Hz . TherefoIn this study, a maximum threshold search time of 7 min was set for ASSR due to testing time constraints. However, in some participants no thresholds were establish during this 7 min time frame and ASSR thresholds were obtained at all four carrier frequencies for only 36% of the participant sample. For ASSR, it is unknown how much search time should be allowed for thresholds to be established, highlighting another ASSR protocol element that requires refining and further research to improve methodological quality and clinical application.Furthermore, this study only included participants with normal hearing or mild hearing loss, which does not provide full insight into the use of ASSR for testing hearing acuity in older adults. Previous reports indicate that ASSR thresholds are closer to PTA thresholds in participants with sensorineural hearing loss in comparison to normal hearing participants , 36, 61.The findings of the present study provide evidence to indicate that ASSR may be a valuable tool in estimating objective frequency-specific hearing thresholds in older adults. Though there is increased risk of false positive, due to over estimation of HL, ASSR is still reliable in assessing HL. Threshold differences between ASSR and the gold standard PTA were, for the majority of participants, within clinically acceptable ranges, thus ASSR can be useful in identifying HL in order to create hearing treatment plans for older adults who are unable to complete behavioral PTA. However, additional research is required to determine optimal parameters of ASSR for threshold estimation in older adults in order to increase its consistency and reliability, as well as eliminate some of the limitations associated with this technique. More research is also required to define modulation frequencies that are more suitable for older adults, which could provide valuable information to inform ASSR testing protocols for them as well as acquisition system manufacturers. Defining specific correction factors that take into account the patient's age, degree of HL and are specific for the carrier frequency can also help improve the methodological quality of ASSR.HT, DJ, WM, HS, and RM conceived the idea for this study. HT collected hearing data with the supervision of DJ. HT prepared the initial draft with input from DJ, WM, and HS. All authors contributed to the development of the idea of this manuscript, as well as contributed to the revision of the manuscript. All authors approved for the manuscript to be submitted.This work was supported by the Australian Government Research Training Program Scholarship at The University of Western Australia; and Australian Alzheimer's Research Foundation.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Education and advice is provided for tinnitus management in all UK audiology clinics. Sound therapy, including provision of hearing aids may be offered, but this is often dependent on a clinician’s decision rather than UK policy. This inconsistent management reflects a lack of evidence around the effectiveness of hearing aids for tinnitus. This open-label, two-arm multicentre randomised controlled feasibility trial gathered data around recruitment, acceptability and outcome assessments to determine the feasibility of conducting a large randomised controlled trial investigating the effectiveness of hearing aids for tinnitus management.n = 41) or TAU plus hearing aids (n = 42). Outcomes were collected by questionnaires 12 weeks after randomisation. After participation, interviews were conducted with a subset of both participants and clinicians from each trial centre.Adults referred to audiology for tinnitus, with an aidable hearing loss were recruited at five UK audiology clinics. They were randomised 1:1 to either education and advice , Eighty three participants from five sites were randomised. Non-aidable hearing loss was the main reason for ineligibility to participate in the trial reported by the sites. Seventy three percent of participants returned the 12-week questionnaires, with return rates by site ranging from 61 to 100%. Fifteen out of 33 participants (45%) reported using hearing aids for the clinician-recommended time, or longer, during the day. The Tinnitus Functional Index (TFI) was the outcome measure most responsive to change. The majority of participants also agreed it was relevant to their tinnitus and hearing loss. Qualitative data demonstrated that the trial was acceptable to participants. Feedback from clinicians revealed a potential lack of equipoise. It also highlighted the differences in referral and treatment pathways between departments and differences in audiometric criteria for fitting hearing aids. Health economic measures were well completed for those returned. No change in health-related quality of life was observed. Costs were higher in the intervention arm, but self-reports of healthcare service use indicated participant confusion in treatment pathways.This feasibility trial is the first step towards obtaining high quality evidence to determine potential clinical effectiveness and cost effectiveness of hearing aids for tinnitus versus usual care. A definitive trial was deemed to be feasible, with some modifications based on feasibility findings and using the TFI as the primary outcome.This trial was funded by the National Institute for Health Research, Research for Patient Benefit Programme  and registered with ISRCTN (ISRCTN14218416).The online version contains supplementary material available at 10.1186/s40814-022-01188-9. This trial gathered data around recruitment, acceptability and outcome assessments to determine the feasibility of conducting a large randomised controlled trial to determine the effectiveness of hearing aids for tinnitus management.A definitive RCT is feasible, providing design optimisation based on the feasibility findings are introduced into the design of future trials and using the Tinnitus Functional Index as the primary outcome.The design of the definitive trial will need to take into consideration current differences between audiology departments in terms of referral and treatment pathways and hearing aid fitting criteria, and make improvements on the quality of information given to participants at time of recruitment.Tinnitus, the awareness of a sound in the absence of an external source, is a major problem affecting 10–30% of the adult population . It is aTinnitus is associated with pathological neural activity in the central auditory system, possibly resulting from a maladaptive response to a peripheral lesion (hearing loss); several structures in the central auditory system, such as the dorsal cochlear nucleus, inferior colliculus, and auditory cortex have been implicated as possible sites for tinnitus generation . Animal Both the prevalence and impacts on quality of life, tinnitus represents a significant burden on healthcare services. An estimated 0.75 million primary care consultations where tinnitus is the primary complaint take place each year in the England alone . The annIn the UK, the most common management strategy for patients presenting with bothersome tinnitus is education and advice. This typically includes explanations of the aetiology of tinnitus and its association with hearing loss, education about lifestyle factors that may have positive or negative effects on the perception of tinnitus and a description of available management strategies . Some auThe primary function of a digital hearing aid is to amplify and modulate sound to make it more accessible and to aid communication. Using hearing aids in tinnitus management has been proposed since the 1940s . HoweverDespite these proposed benefits, there is no robust evidence or consensus on whether a person with tinnitus would or would not benefit from amplification in addition to the education and advice provided as standard care. A Cochrane review of sound therapy for the management of tinnitus cited a lack of high quality evidence leading to variability in clinical practice in the UK  and acroA definitive trial assessing digital hearing aids for tinnitus is needed. However, there are few examples of multi-centre randomised controlled trials (RCT) in UK audiology clinics on which to inform the design and conduct of such a trial. As such, it was essential to first perform a feasibility trial. The HUSH trial (Hearing Aids for Tinnitus with Hearing Loss) was the first step towards a definitive trial to provide high quality evidence for the clinical effectiveness and cost effectiveness of hearing aid provision for tinnitus It investigated the feasibility and acceptability of a RCT comparing (i) education and advice ) and (ii) TAU plus digital hearing aids for the management of people with tinnitus and hearing loss.Objectives around recruitment, outcome assessment, and acceptability were defined to (i) determine feasibility of a multicentre RCT comparing TAU and TAU plus hearing aids, (ii) optimise the design of a definitive RCT and (iii) determine which outcome measures are most relevant for patients to guide primary outcome selection for a definitive trial.The trial was registered prior to the start of recruitment . The previously published trial protocol provides full details of the study design and methods , and as This was an open-label, two-arm, multicentre randomised (1:1) controlled feasibility trial comparing the effectiveness and cost effectiveness of ‘treatment as usual’ (TAU) to TAU plus hearing aids for the management of tinnitus in patients with hearing loss. The trial had a nested interview study to look at feedback from participants and clinicians regarding the trial and its intervention and also an economic evaluation to determine feasibility and appropriateness of tools for collecting resource use and health-related quality of life.Adults (18 years or over) presenting to clinic with a primary complaint of tinnitus, as confirmed by the assessing audiologist, were recruited from five UK audiology departments. All participants provided written informed consent. Potential participants were excluded if their tinnitus was of a medically treatable origin, if they had used a hearing aid in the last 12 months or if they currently used any combination device or behind the ear sound generator, as these were considered to be concomitant treatments. Additional exclusions were the inability to communicate in written English, which would have prevented them from completing all outcome measures, and having started or stopped medication for anxiety or depression within the last 3 months, which could influence the efficacy of the interventions or the interpretation of changes in patient reported outcome measures (PROM).From October 2018 to September 2019, potential participants were screened from tinnitus clinic lists and sent a participant information sheet in the post providing information about the trial. During their routine care appointment, the patient was approached to take part in the study by the audiologist if they were deemed eligible. After written informed consent was given, audiometry and the Tinnitus Functional Index were first undertaken to provide the necessary minimisation variables  for randomisation (1:1). The local site randomised the participant using a concealed, secure web-based system developed by the NCTU and held on a secure UoN server.After randomisation, both groups received education and support (TAU) according to local practice. TAU could not include any ear-level device such as an at-ear sound generator. The intervention group also received hearing aids which were fitted according to standard procedures. This had to be fitted either on the same day as randomisation or within a 4-week window to allow for trial sites where the patient pathway did not allow for hearing aid fitting on the same day as the assessment appointment. At the time of fitting the audiologist gave daily usage recommendations. Adherence was checked at the end of the 12-week treatment phase, comparing participant reported usage in the questionnaire to this clinician-recommended usage.As hearing aids were offered only to the intervention group, blinding of treatment allocation was not possible for the clinician or the participant. Members of the trial management team were also unblinded for purposes of questionnaire administration. The trial statistician, health economist and chief investigator remained blinded to all treatment allocations until after database lock.Outcomes to determine the feasibility and acceptability of a large definitive trial were collected. A range of PROM was also gathered to inform the choice of primary outcome for a definitive trial.Recruitment: number and proportion of eligible and randomised patients; patient characteristics; adherence; retention; data completeness; components of TAU; hearing aid fitting parameters; re-referral rates; feasibility of collecting healthcare resource use and safety data. 2. Acceptability: hearing aid adherence; feedback from participants and clinicians regarding trial conduct and design as well as the intervention. 3. Outcomes: participant opinion of PROM; distribution of PROM; estimation of clinically important differences of PROM.1. The following PROMs were collected at baseline and 12 weeks: tinnitus symptom severity  ), hearinPROMs were collected at baseline appointments and in 12 week-follow-up questionnaires between November 2018 and December 2019, using paper questionnaires either given or sent directly to the participants. Data was entered into the eCRF upon return of the questionnaires to the trial coordinating centre. Non-return of the questionnaires was followed up using a combination of post, email, text and telephone reminders. Recruitment outcomes were taken from data collected and entered by clinicians during the running of the trial at site, and qualitative data was collected from interviews with participants and clinicians after the end of their individual involvement in the trial.Since this was a feasibility trial, a formal calculation was not appropriate. The trial aimed to randomise 100 participants over 12 months from five recruiting centres to explore feasibility parameters such as methods of recruitment and recruitment and retention rates in different types of centres. This sample size enabled estimation of a retention rate of greater than 80% to within 8% points of the true value with 95% confidence. Together with information from qualitative interviews and the information collected about PROMs which will inform the primary outcome and sample size for a future trial, this provided sufficient to determine feasibility for a future definitive trial. The five sites were each given a target of randomising 20 participants.The trial was analysed in accordance with a full statistical analysis plan, finalised prior to database lock and release of treatment allocations. Formal statistical testing and interim analyses were not undertaken as the aims of this trial were to assess feasibility. Descriptive summaries were produced for total and site recruitment rates, the number and proportion of participants who underwent each allocated procedure, completeness of data collection at baseline and 12 weeks by trial arms and outcome data at baseline and 12 weeks.To guide the choice of primary outcome for a definitive trial, analyses of PROMs, independent of treatment group, were performed and taken into consideration alongside patient views captured in the nested interview study (described below).For each of the five PROMs, total scores at baseline and 12 weeks, and change from baseline to 12 weeks were summarised. Scores for participants who answered ‘slightly improved’ or ‘moderately improved’ on the global improvement questions were used as an anchor to investigate the smallest difference that participants perceived to be beneficial. Minimum clinically important effects for each PROM was estimated using three standard anchor-based responsiveness statistics : (i) staA nested interview study took place alongside the trial to assess the feasibility and acceptability of trial processes and the intervention and to further consider the patient perspective in regard to PROMs. Upon completion of individual participation in the trial, semi-structured telephone interviews were conducted with both study participants and healthcare professionals representing all study centres. Participants were be selected purposively to capture a range of different experiences and treatment outcomes. After recruitment activities have ceased, clinical staff at each study site was interviewed to review their experience of the trial in terms of participant recruitment and integrating the research within clinical care. Interviews were recorded, transcribed verbatim in accordance with the study protocol and analysed using a framework approach , 38 to sA trial-specific proforma was developed to assess the feasibility of capturing healthcare resource use, and the appropriateness of the health-related quality of life (HRQoL) instruments, for remote data collection in this population. Measures were taken at baseline (HRQoL) and at 12 weeks (HRQoL + resource use). The purpose-built questionnaire, which collected data on healthcare resource use, took an NHS and societal perspective and included variables for trial attributable service and device use, such as audiologist/hearing therapist contacts, alongside other external pathways such as primary and community services. Applicable unit costings were derived from the National Cost Collection  and the The trial management group (TMG) met on a monthly basis over the course of the trial, and an independent trial steering committee (TSC) maintained regular overall oversight for the conduct of the trial. The TMG and the TSC took a joint decision on final assessment of feasibility using both the quantitative and qualitative data gathered over the course of the trial.The feasibility assessment was adapted from that proposed by Thyer et al. . The trin = 191, 32%), previous use of hearing aids in the last 12 months , no diagnosis of tinnitus  and starting or stopping medication for anxiety/depression in the last 3 months .Five sites were open for recruitment between 15 October and 3 December 2018. All sites closed to recruitment on 30 September 2019. During the recruitment period, 1737 patients were referred to these centres for tinnitus. Of those, 592 (34%) were pre-screened for trial eligibility, either prior to appointment based on existing medical records or at the appointment itself: 155 (26%) were eligible to participate in the trial  eligible patients were randomised . Three out of five sites met or exceeded their recruitment target of 20 participants  men and 32 (39%) women were randomised with a mean age of 58 (SD = 13.6) years. Seventy-nine (95%) participants were white. Median duration of tinnitus was 3.8 years (range 0.4–40 years).Eighty-two participants received their allocated treatment. One participant randomised to receive hearing aids was not fitted due to medical reasons identified after randomisation. Twenty-four participants received bilateral (59%) and 17 (41%) unilateral hearing aids.Fifteen out of the 33 participants who returned their end of trial questionnaires (45%) reported using hearing aids for the time recommended by the clinician or longer during the day (during weeks 11 and 12). Thirteen participants (39%) reported using hearing aids for less time during the day than recommended by clinicians. Five participants (15%) reported that they were not wearing their hearing aids at all during weeks 11 and 12. Reported reasons for non-use were as follows: (i) pain when using, (ii) made no difference to tinnitus, (iii) did not get used to the HAs, (iv) ear dryness needing treatment and (v) HAs made them more aware of tinnitus.Sixty-one participants (73%) returned the 12-week questionnaire packs  … I looked through the questionnaire and there was nothing to say ‘did you actually wear the hearing aids when you are supposed to?’, so I was like that’s a bit silly because I actually didn’t wear the hearing aids so I didn’t want to fill it out to look like I’d got no benefit but that would have been because I didn’t wear the hearing aids for 12 weeks […] so I didn’t want to give false results.Participant 16: Some of the questions were a little bit repetitive but written in different ways. I can’t actually give you an example at this moment in time but I did find that I seemed to be answering the same thing again.[…] it might have been there to see if well maybe like a bit of a trick question, maybe if you answered one one way and one another way then like are you really at the right answer.The potential value of a hearing aid for tinnitus was not universally recognised by all participants, with some assuming that the provision of a hearing aid was primarily for their hearing loss rather than for their tinnitus. Some participants experienced technical issues with their hearing aids, and some struggled to acclimatise to them.Participant 6: When she said I’m going to give you a hearing aid I thought that would improve my hearing but it hasn’t and in actual fact I don’t know if I should say this or not, I don’t think it’s working. [A friend] said, she asked me ‘I see you’ve got a hearing aid’, I said, ‘yes but I don’t think it’s working’ and I told her all about what had happened and I said, ‘but I’m going to [City] on Monday to see my daughter I was thinking of calling in the [Hospital]’ and she said, ‘well I think you have got to accept that they may have given you a placebo’.Healthcare professionals highlighted different local referral and treatment pathways and indicated that incorporating the research processes into routine clinical practice was difficult and a possible barrier to effective recruitment.Professional 8: We used our direct referral clinics as the targeted patients for the study and I think that’s why our recruitment numbers were low because essentially a lot of those patients needed medical opinion or needed some intervention before we could go on to do the standard care or the hearing aid and some of them would have normal hearing because they had just been referred in for tinnitus so actually we found it quite difficult to recruit into the study because they were coming in blind we had no idea of whether they were going to have hearing loss or whether they were going to be suitable to be recruited into the study.It was also clear that differences in local/professional practice influenced how professionals engaged with the recruitment process—where they already routinely recommended hearing aids there was some anxiety about withholding treatment.Professional 4: We personally found it challenging because we do so much work around hearing aids with our tinnitus patients we had to sort of re-word everything and personally felt that we weren’t giving the best service that we knew we could offer because we knew the patients would probably benefit from hearing aids in the long term.Despite a dedicated research training day being provided to all sites, the healthcare professionals indicated that additional research training is needed. Some healthcare professionals found notions of equipoise and randomisation difficult to accommodate within their clinical practice and lacked ‘research confidence’.Professional 7: It’s hard, it’s very hard and I go to the trial management meetings and we talk about equipoise and we know we are not in equipoise for this because we know that hearing aids work and you have to put on your actors face and say we don’t have the evidence to proves this works we know that in some cases it does work but we don’t have the evidence to prove it, would you be willing to be part of the trial to do that.Professional 3: I knew very, very little about research and I’d say when as a general clinician we are not that used to doing research so it’s probably a little bit of a daunting task and as well I think it was felt they had a lot of training in the beginning and I could see there was a lot of training going into things and people had done presentations but by the time the study actually got up and running it was quite some time after that.We report summary statistics self-reported service and device use in Table The questionnaires were well completed for those which were returned. The TAU group returned 28/41 (68.3%) of the questionnaires, of which 26/28 (93%) provided complete case data on healthcare resource use. A larger number were returned in the TAU plus hearing aids group 33/42 (78.6%), corresponding to 29/33 (88%) complete cases.The non-complete cases had responded to almost all individual questions, and completion of item level responses were balanced between groups. Participants in both arms reported of receiving an initial assessment and fitting of hearing aids with an audiologist/hearing therapist and to a lesser degree of receipt of hearing aids themselves. Two participants in each of the groups specified receipt of private healthcare services, and one in each group reported receipt of medicines (either NHS or privately prescribed). The resource burden of treating this population largely falls upon the NHS. Costs for received private services and devices were very poorly completed and collection of such items needs refinement going forwards.Table i)Determining feasibility of a multicentre RCT comparing TAU and TAU plus hearing aidsOver 80% of the recruitment target was achieved.All sites remained open throughout the duration of the trial recruitment phase, with 3/5 sites achieving or surpassing their recruitment targets. The common denominators across these 3 sites were engaged staff and robust research infrastructure.The trial gathered sufficient quantitative and qualitative data upon which the TMG and TSC was able to base a formal feasibility assessment in accordance with the pre-determined feasibility criteria:The overall trial retention rate at 12 weeks was 73%, with return rates ranging from 61 to 100% between centres. The participant interviews highlighted reasons for non-return that can be addressed.The TFI, identified as relevant to tinnitus and hearing loss by the majority of participants, also showed that it was responsive to change. Sufficient data was also gathered to establish variability and a minimal clinically important difference (MCID) based on the data for this trial, to aid in the sample size calculation for a randomised controlled trial with the TFI overall score as the primary outcome.3.Both participants and healthcare professionals expressed a conviction in the importance of the trial and acceptability of the trial design. Any areas of the trial design requiring modifications were clearly articulated, and solutions could be implemented to address all highlighted areas.The TSC also noted that safety data were successfully collected and that incidences of adverse events are likely to be low in a definitive trial.ii)Optimising the design of a definitive RCTAt the final results reveal meeting, the oversight committees concluded that a definitive RCT would be both feasible and safe, and providing design optimisations based on the present trial findings, delivery of a full RCT is plausible within a 5-year study period.and tinnitus. This variability resulted mainly from differences in hearing aid eligibility criteria imposed by different Clinical Commissioning Groups (CCGs). Those sites, where CCGs left the decisions about hearing aids eligibility to clinicians, tended to fit hearing aids for milder hearing losses.Recruitment: ‘Non-aidable hearing loss’ was the main reason for ineligibility reported by the centres. We made an attempt during the trial design phase to standardise the definition of ‘aidable hearing loss’; however, clinicians were not able to come to a consensus as they were influenced by their local guidelines and personal beliefs. In order to better understand the prevalence of this reason given on the screening logs, during the course of the trial participating sites were asked to define what constituted the local audiometric criteria for a ‘non-aidable’ hearing loss. There was a marked variability in audiometric criteria for fitting hearing aids between centres, with some fitting much milder hearing losses than others. The mildest criteria that clinicians were using were hearing loss of 15 dB or more at at least one audiometric frequency up to 8 kHz. The most conservative criteria reported by site were average hearing loss of more than 30 dB at at least three mid-frequencies . These criteria were reported to be the generic fitting criteria for hearing loss, rather than specific criteria for patients with hearing loss It is possible that clinics who choose to fit milder losses are influenced by findings such as those from the review by Ferguson and colleagues  who concFurther definitive trial development work should involve seeking clinical consensus to design the inclusion criteria that combine audiometric criteria and perceived hearing difficulties to address the population with tinnitus where clinical practice is the most variable. Such an approach might also give participating clinicians more confidence to recruit patients to take part in the trial, randomise them, and target the audiology departments that do not normally provide hearing aids for people with such characteristics. This should also address the issue of lack of equipoise amongst clinicians and excluding large numbers of participants from the trial due to ‘non-aidable hearing loss’.The interviews suggested that successful recruitment of a future trial will also depend on sufficient flexibility within the protocol to allow for local variations in the patient pathway. It is important that patients can be identified and offered the trial, regardless of their referral pathway, and of minimum impact to the scheduling of routine clinical practice appointments.There was also a marked variability between centres in respect to recruitment rates. Experience of conducting research and/or the support of dedicated research staff  were key to on site trial delivery. As many audiologists do not have experience participating in large RCTs, there is a need for detailed and targeted research training for these healthcare professionals to be factored into the trial in terms of both time and cost. Further training will also improve the quality of information provided to participants, helping the aims and processes of the trial to be clear to all who are randomised.For the definitive trial, since it is the intention to include only the TFI and a reduced number of other PROMs, the questionnaire pack will be shorter, reducing participant burden. It will also be offered in an online format in addition to paper, which some participants may find more convenient. Clinicians recruiting into the trial will receive training to help the participants understand the importance of returning the questionnaire packs, irrespective of adherence to treatment allocation or perceived improvement in tinnitus. Further PPI work will be undertaken to determine acceptable ways of explaining the value of these questionnaires to participants, and in which formats and at what times reminders would be most helpful for this population.There is a suggestion, but no conclusive evidence, to suggest that hearing aid benefit is associated with increased usage. It is however a methodological challenge to quantify what is adequate usage of a hearing aid, as this could vary from patient to patient, dependent on lifestyle factors. In the HUSH feasibility trial, we looked at compliance as hours of participant-reported use compared to hours of clinician-recommended use. The compliance reported here for the intervention group was similar aids similar to recent published data on hearing aid usage that reported that 30% of patients given hearing aids under-use them, and a further 20% do not use them at all . Howeveriii)Informing the choice of primary outcome for a definitive trialParticipants in each of the groups specified the receipt of hearing services . This may signal heterogeneity in site practice leading to a misunderstanding of patient care pathways and would not represent the true resource burden to the NHS. Similarly, feedback from clinicians indicated that there is considerable variance in the costs of hearing aids between sites which were not captured by our questionnaires. A definitive trial would benefit from a detailed breakdown of both the initial patient pathways and the costs of hearing aids, by device, across sites. Questionnaires should be further refined for the collection of societal costs, such as private services and productivity losses.As the core outcome set for tinnitus is still under development , at the Eighty-four percent of patients who returned their 12-week questionnaire agreed or strongly agreed that the TFI was a relevant measure for tinnitus and hearing loss, making it the most highly rated of the PROMs administered in terms of relevance. It also showed the highest value for responsiveness.There is also ample empirical evidence to support both the development and validation of the TFI, giving confidence for its use as a primary outcome in a definitive RCT. The TFI was developed to be (1) discriminative to provide measures of tinnitus distress, (2) evaluative to provide a responsive measure of treatment-related changes and (3) comprehensive to cover multiple domains of tinnitus severity. The TFI has been evaluated for use in clinical practice and research in the UK , 53. ThiThe primary purpose of fitting hearing aids is to reduce hearing difficulties and improve communication, which was observed as the greater change from baseline for the HHIE for the hearing aid group in the present study. Improvement in hearing and communication might lead to reduction in stress and anxiety that may be associated with hearing difficulties and in consequence may lead to changes in self-reported measures of tinnitus symptom severity . MoreoveThe HUSH trial was the first trial to assess the feasibility of conducting a multi-centre randomised controlled trial of effectiveness of hearing aids for tinnitus in UK audiology departments. It demonstrated that a definitive RCT is feasible, providing optimisations based on feasibility findings are introduced into the design of future trials. The design of the definitive trial will need to take into consideration current differences between audiology departments in terms of referral and treatment pathways and hearing aid fitting criteria. Including audiometric criteria in trial eligibility will help to target the population of patients with mild hearing loss for whom clinical practice is most variable. This could address the clinical uncertainties around what constitutes an aidable loss and lack of equipoise around who should be included in trial participation. The TFI appears to be the most suitable measure for use as the primary outcome, supported by other secondary outcome measures that this trial showed were important to people with tinnitus. The defining and recording of compliance will also be a methodological challenge for consideration in all future trials of hearing device usage.Whilst the results of a future definitive trial cannot be guaranteed based on the current feasibility findings, it is nevertheless likely that such a trial will be a needed step forwards towards patient satisfaction and potential savings to the healthcare system. A recent study showed low patient satisfaction with tinnitus management, resulting in a time consuming and costly ‘revolving door’ system, with about 37% of tinnitus referred more than once to secondary care . A definAdditionally, as there have been relatively few large-scale RCTs engaging UK audiology clinics, there is a gap in research capacity and skills within NHS hearing services. This trial was a step towards supporting audiologists to become confident researchers. Importantly, audiologist and trialist experiences from HUSH are feeding into collective national efforts to develop widespread and accessible training to boost research skills, knowledge and confidence amongst health care professionals conducting trials within NHS hearing services and informing the design of future trials in these contexts and patient populations. It is hoped that this work which the HUSH trial has influenced will continue to prepare the workforce for the successful delivery of future large-scale RCTs within audiology clinics.Additional file 1. CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial.Additional file 2. Appendix with additional tables.


Neurofibromatosis type 2 (NF2) is a rare disease, characterized by a mutation in the long arm of chromosome 22 that leads to the development of bilateral vestibular schwannomas (VS) in approximately 90% of patients with this syndrome.4The control of tumor growth and hearing preservation are the cornerstones of its treatment, which can be carried out by surgery or radiotherapy, considering the size of the lesion and the presence of functional hearing.The possibilities of hearing rehabilitation range from the adaptation of conventional hearing aids (HA) to auditory brainstem implant (ABI). In the latter case, hearing results are limited, because this procedure only enables the detection of sound and acts as an auxilliary for lip reading. Thus, several authors consider microsurgery with preservation of the cochlear nerve and use of a cochlear implant as the best therapeutic option.6GMC, a 50-year-old male with progressive bilateral hearing loss for 2 years, related recent dizziness, bilateral tinnitus and headache. At physical examination, this patient revealed normal otoscopy, no nystagmus and a positive sensitized Romberg test with deviation to the right; no changes were observed in other cranial nerves.Audiometry revealed bilateral sensorineural hearing loss (43 dB for the right ear and >80 dB for the left ear) and the auditory brainstem evoked potential was absent in the left ear. Magnetic resonance imaging (MRI) showed solid lesions with irregular borders occupying the inside of both internal auditory canals .Figure 1At that time, it was suggested left tumor surgical removal; however, given the patient's refusal, our decision was for bilateral fractionated stereotactic radiotherapy and use of hearing aids.A year after radiotherapy, even with the tumor under control, our patient developed progression of his hearing impairment to left anacusis and severe right sensorineural hearing loss , with 30% discrimination of sentences in an open context using bilateral hearing aids. Thus, a right-ear cochlear implant ear was recommended, due to its smaller tumor and a residual hearing. Twelve months after implantation, the patient discriminates 100% of Ling's six-sound test, monosyllables, vowels and sentences in an open context.The first cochlear implant after surgical removal of VC was reported in 1992. A decade later, we found in our search reports of 37 patients who underwent complete resection of VS, combined with a cochlear implant, with possibility of discrimination in an open context in 68% of cases.In 2013, a Belgian study related hearing preservation with radiosurgery in the treatment of NF2 in a series of 12 patients, and 78% had functional hearing (discrimination >70%) up to 2 years after radiation. However, it is important to point out that hearing impairment can happen even after several years, due to a degeneration of the stria vascularis secondary to radiation.In 2010, Trotter et al. published the results of cochlear implants in two patients with NF2 submitted to radiotherapy in the ear that received the implant. One of these patients reached 96% of discrimination of sentences, and the other, 72%. A systematic review carried out in 2012 showed that among eight patients with NF2 and deafness treated with radiosurgery, six achieved discrimination sentences in an open context with the use of a cochlear implant.6In our case, the patient with NF2 underwent fractioned stereotactic radiotherapy and a cochlear implant after tumor control; one year after implantation, this patient showed good results, being able to understand well what is spoken in a spontaneous conversation, denoting a good comprehension of speech and of its suprasegmentar traits, such as rhythm and intonation.The use of a cochlear implant in patients with NF2 treated with radiotherapy is still a scarcely reported auditory rehabilitation strategy, but that has proven effective, as in the present case.The authors declare no conflicts of interest.