This study introduces a digital assessment tool for asynchronous and remote ear-nose-and-throat (ENT) specialist assessment screening for complicated hearing loss and serious ear disorders in hearing-impaired adults prior to hearing aid (HA) treatment. The +60 population will nearly double from 12% to 22% between 2015 and 2050 increasing the incidence of age-induced hearing impairment and the need for hearing rehabilitation. If un-diagnosed, age-related hearing loss negatively affects quality of life by accelerating social distancing and early retirement as well as increasing risk of anxiety, depression, and dementia. Therefore, innovative measures are essential to provide timely diagnostics and treatment.A total of 751 hearing-impaired adults without previous HA usage or experience were randomly assigned to digital or physical ENT specialist assessment screening prior to HA treatment initiation in 20 public and private hearing rehabilitation and ENT specialist clinics in the North Denmark Region. A total of 501 test group participants were assigned to digital assessment screening and 250 control group participants to physical assessment screening prior to HA treatment.In all, 658 (88%) participants completed the trial and were eligible for analysis. Digital screening sensitivity  0.71–0.94) was significantly higher than physical screening sensitivity . Screening specificity was high for both assessment methods.In a setting where hearing-impaired adults were assessed for HA treatment, digital ENT specialist assessment screening did not compromise patient safety or increase the risk of misdiagnosis in patients with complicated hearing loss and/or serious ear disorders when compared to physical ENT specialist assessment screening.https://clinicaltrials.gov/ct2/show/NCT05154539, identifier: NCT05154539. Hearing loss (HL) negatively affects quality of life by accelerating social distancing and early retirement and by increasing the risk of anxiety, depression, and dementia , 2. HoweBefore acquiring a HA in a private or public hearing rehabilitation clinic, hearing-impaired Danes without prior HA usage or experience need a physical ear-nose-and-throat (ENT) specialist assessment (PESA) screening for complicated HL and/or serious ear disorders that need specialized hospital treatment. This practice is in line with current national guidelines and legislation , 8; howeThe RESA screening method has been tested in 751 individuals in a randomized controlled trial coined “The Innovation of Hearing rehabilitation and Effects of Reform (InHEAR) trial” in the North Denmark Region. The trial aimed to investigate whether RESA screening can be performed in hearing-impaired adults prior to treatment without misdiagnosing cases of complicated HL and serious ear disorders. The aim of this study is firstly to present primary outcomes from the InHEAR-trial: RESA vs. PESA screening accuracy for complicated HL and serious ear disorders in hearing-impaired adults, and secondly to discuss whether RESA screening is a safe and feasible method for digital assessment of hearing-impaired adults prior to HA treatment in the future. Secondary trial outcomes regarding self-reported HA benefit and patient satisfaction in HA recipients undergoing RESA screening will be reported elsewhere.The InHEAR trial was an open label, randomized controlled trial with two arms and a random 2:1 allocation ratio. Participants allocated to the RESA intervention arm were randomized into two sub-groups: Test group 1 (TG1) and Test group 2 (TG2). TG1 participants were examined and treated in private hearing rehabilitation clinics; TG2, in public hearing rehabilitation clinics. The intervention methodology was identical in the two test groups. In the second arm, control group (CG) participants were assessed physically and in-person by private ENT specialists in accordance with current practice and existing Danish guidelines . The triPatient organization representatives, public and private hearing healthcare professionals and collaborators, and representatives from the hearing aid industry were enrolled in a supportive trial committee and participated in finalizing the trial design and selecting the outcome measures prior to trial commencement. Semi-annual meetings enabled committee members to provide critical comments and questions throughout the trial course.Adult individuals aged 18 years or more with subjective HL or hearing difficulties and without associated acute or chronic ear-related symptoms such as earache, ear pain, or discharge from the ears were eligible for participation. Previous HA users and individuals who were unable to understand or read Danish, with severe dementia, or with massive comorbidity that would render impossible their participation, consent, completion of the study questionnaire, or physical attendance at one or more trial stages were not eligible for participation.A participant registration form was published on a Facebook page maintained by the North Denmark Region via a link to an online survey software where personal data and contact information of interested and potential participants were registered . Subsequently, eligible candidates who met the inclusion criteria received a phone call by one of two study secretaries or a key study administrator who offered additional information about study participation. Clinical study data were obtained throughout the trial by project staff members  in 12 private and five public hearing rehabilitation clinics and in three private ENT specialist clinics located in the North Denmark Region. Study data were collected and managed using a Research Electronic Data Capture system (REDCap®) hosted at Aalborg University Hospital , 10.At Stage 1, CG participants were examined and assessed physically and in-person by private ENT specialists in accordance with current national guidelines . In contThe standardized test package was performed exclusively on TG1 and TG2 participants undergoing RESA screening. The medical history was obtained using the Danish adapted electronic version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire ; a tool Audiometry test settings, performance, and equipment matched the required standards as described in the Danish Executive Order on HA treatments . The tesStill images of the EAC and the tympanic membrane were obtained digitally by video otoscopy. Although digital video-otoscopic imaging is becoming a more widely known and accepted diagnostic tool for ear diseases among general practitioners and ENT specialists –17, digiThe standardized test package results were assessed digitally, remotely, and individually by four experienced ENT specialists: two ENT specialists with medical audiology expertise and two private ENT specialists. All TG participants were randomly allocated to one of the four digital ENT specialist assessors whose assessment decision was subsequently applied at the treatment stage. The participants were blinded to assessment allocation as were the remote ENT specialist assessors.A pure-tone average (PTA) hearing level of 20 dB or better was regarded normal. PTA referred to the average air conduction (AC) hearing thresholds at 500, 1,000, 2,000, and 4,000 Hz (PTA-4). To ensure that serious ear disorders were not overlooked in the intervention groups, TG participants with normal hearing undergoing RESA at Stage 1 were re-examined physically by an ENT specialist with medical audiology expertise before concluding their trial course.Simple HL included HL in the subcategories mild (25–40 dB hearing level AC thresholds) and moderate (45–60 dB hearing level AC thresholds) without concurrent serious ear disorders. Participants with asymmetric sensorineural mild or moderate HL of 15 dB or more at two neighboring frequencies were offered additional magnetic resonance imaging (MRI) of the internal auditory canal to rule out retro-cochlear pathology such as a vestibular schwannoma. Brain stem audiometry (ABR) was applied in case of MRI contraindications. TG1 participants with simple HL had HAs fitted in private hearing rehabilitation clinics; TG2 participants, in public hearing rehabilitation clinics. CG participants with simple HL were allowed to choose between a private or public hearing rehabilitation clinic for HA fitting. Regardless of group affiliation, all participants were treated in line with current national clinical guidelines on HL management .Complicated HL included symmetric and asymmetric HL exceeding the 61 dB hearing level AC thresholds and mild or moderate HL with severe PTA-4 asymmetry exceeding 30 dB in AC hearing thresholds between the two ears and/or a difference of 20% or more in speech discrimination score (DS) between the two ears. Complicated HL was diagnosed in accordance with the 2015 Danish National Clinical Guideline (NCG) criteria on ENT specialist assessment and referral of patients with HL . The traRegardless of group affiliation, all participants diagnosed with HL (simple and complicated) or serious ear disorders were re-assessed by experienced ENT specialists subspecialized in medical audiology or otology at the Department of Audiology at Aalborg University Hospital 2–4 months after initiating HA treatment. A 30-minute, in-person patient-physician consultation was conducted and a oto-microscopy was performed by the ENT specialist for objective assessment of the EAC and the tympanic membrane. This physical ENT specialist re-assessment at Stage 3 served as the gold standard with which all previous remote or in-person Stage 1 ENT specialist assessments were compared.Primary outcome measures comprised RESA vs. PESA screening sensitivity and specificity of TG and CG participants, respectively, for complicated HL and serious ear disorders. Remote and in-person ENT specialist assessments at Stage 1 in TG and CG participants, respectively, were compared to physical gold standard ENT specialist assessments at Stage 3, and screening sensitivity and specificity were calculated and analyzed for TG1, TG2, and CG participants, respectively. All ENT specialist assessments at Stages 1 and 3 were thoroughly cross reviewed and revised by two key project management members in case of obvious registration errors or project guideline misconceptions.RESA screening applicability in hearing-impaired individuals depends on how accurately remote ENT specialist assessors identify cases of complicated HL and serious ear disorders. However, some ear disorders are rare such as cholesteatoma with 350 new cases  and vestibular schwannoma with 200 new cases  diagnosed yearly in Denmark . The incP value of 0.05 , and a A total of 782 individuals aged 18 years or more with subjective HL were recruited between March, 2021, and September, 2021. The trial was completed in May 2022. A total of 751 participants signed the informed consent form and were eligible for randomization, and 658 (88%) participants completed the trial and were eligible for analysis. A total of 40 (5%) participants were lost to follow-up, 52 (7%) participants withdrew from the study due to illness, or for personal or unknown reasons, and one participant died during the trial course. Participant flow is shown in No significant difference was found in age and gender composition between the groups . Out of P = 0.006. For PESA screening, sensitivity was 0.20 (0.03–0.56), specificity was 1.00 (0.97–1.00), and the PPV and NPV were 0.67 (0.09–0.99) and 0.96 (0.93–0.98), respectively, P < 0.001. A sub analysis on RESA screening accuracy in TG1 and TG2 participants is shown in P = 0.006. For RESA screening in TG2, sensitivity was 0.82 (0.57–0.96), specificity was 0.96 (0.92–0.98), and the PPV and NPV were 0.64 (0.41–0.83) and 0.98 (0.96–1.00), respectively, P < 0.001.Six TG and eight CG participants undergoing RESA and PESA screening, respectively, were misdiagnosed as “simple” at Stage 1 when compared to the gold standard ENT specialist assessment at Stage 3 . Twelve Another 34 TG participants with complicated HL and/or serious ear disorders were correctly diagnosed at Stage 1, including cases of cholesteatoma, otosclerosis, tympanic membrane perforation, OME, and ETD. In fact, all cases of serious ear disorders that required otologist assessment or intervention in TG participants were correctly assessed by RESA screening at Stage 1.Out of the 445 TG participants who completed the study, the quality of the digital otoscopic images of the tympanic membranes in 130 (29%) TG participants were considered insufficient by the digital ENT specialist assessors at Stage 1 due to blurring, earwax blockage, or insufficient visualization of the tympanic membrane. In 10 of these cases, the oto-microscopic examination at Stage 3 revealed pathological findings of varying degrees of severity such as earwax blockage, EAC atresia, OME, retraction of the tympanic membrane, and cholesteatoma. However, none of these 10 TG participants were misdiagnosed at Stage 1 when compared to the gold standard ENT specialist assessment at Stage 3.This randomized trial found that in a setting where hearing-impaired adults were assessed for treatment, overall RESA screening sensitivity for complicated HL and/or serious ear disorders (85%) was significantly higher than PESA screening sensitivity (20%). The screening specificity was high for both screening methods. Thus, RESA screening does not increase the risk of misdiagnoses of patients with HL prior to treatment initiation and could be a potential gamechanger in future ENT assessment practices in hearing healthcare where demographic changes and scarcity of resources may lead to prolonged diagnostics and treatment delay.Strengths of the study were the large study sample of 751 individuals and the well-organized randomized trial design that eliminated known and unknown confounding variables. A benefit of the public/private cooperation in the study was a cross-sectional RESA method test setting in both private and public healthcare facilities, reflecting the current organization of hearing healthcare in Denmark. Limitations were the lack of blinding of participants and staff. However, the risk of potential experimental biases from participant expectations, from latency between intervention and follow-up stages, and from the influence of other specialist evaluations was considered low. Self-selection bias related to the Facebook-based recruitment strategy must be considered, as volunteering individuals may be younger and healthier, lead healthier lives, and may comply with treatment to a higher degree than older, non-volunteering individuals who may not be as internet literate. Although the 2021 Statistics Denmark report on Danes’ use of information technology shows that 95% of the Danish population between 16 and 74 years were online at least once a day and that 85% were active on social media in 2021 compared with 55% in 2011, social media use seems to decline synchronously with age . Thus, eAnother element to consider when interpreting the results is the complexity of the underlying pathophysiology of hearing and ear disorders and their various clinical manifestations. As the assessment decision often relies on the individual ENT specialist's experience and professional knowledge and on the influence of the patients’ individual opinions and needs, it may not be possible to define and apply a true ENT specialist gold assessment standard for this patient category. However, in the present study, gold standard assessments were made by experienced ENT specialists subspecialized in either medical audiology or otology. Furthermore, assessments were based on a 30-minute in-person consultation with the patient including an audiological assessment and an objective oto-microscopic examination.Finally, it is worth mentioning, that Danish PESA-performing private ENT specialists frequently use clinic staff rather than certified audiology assistants to perform audiological examinations on their patients, why the quality of the audiograms may vary significantly, causing an increase in ENT specialist assessment inaccuracy and misdiagnoses. In the present study, three cases of misdiagnosis on this account reduced PESA screening sensitivity from a potential 50% to 20%. To accommodate this type of problems in the future and to specify the quality requirements for hearing rehabilitation in adults, new national guidelines and recommendations have been outlined and will expectedly be released following an upcoming public consultation round.Asynchronous healthcare technologies utilized in patient portal email messaging, in-app messaging, specialist-to-patient mobile apps, and delayed interview video consultations have been described more frequently in various medical fields such as in radiology, ophthalmology, dermatology, cardiology, pathology, and psychiatry –33. In hRESA screening of hearing-impaired adults has great potential in Denmark and in all developed countries where the standard examination routine involves one or more physical encounters with an ENT specialist. RESA simplifies the course of treatment, prevents prolonged diagnostics and treatment delays, and may also improve socioeconomic resource allocation within hearing rehabilitation healthcare without compromising patient safety or lowering the existing examination standards. These benefits are, however, conditioned by the availability of professional hearing care assistants capable of performing valid audiological examinations that meet the required legal quality standards and of conducting high-quality digital otoscopic imaging of the tympanic membrane. Therefore, professional quality requirements and process guidelines on RESA screening of hearing-impaired adults must be outlined to keep quality standards at the needed high level.In this randomized trial comprising 751 hearing-impaired adults and potential first-time HA users, we found that RESA screening for complicated HL and/or serious ear disorders did not compromise patient safety. Overall, RESA screening accuracy was significantly higher than the screening accuracy of the physical, in-person ENT specialist assessment routine we know and use today. Moving forward, quality requirements and RESA screening guidelines are needed to ensure the performance of high-quality audiological examinations by professional hearing care assistants. Additional validation and adjustment of the tool is conditioned by regional or national implementation. If these requirements are met, the multivariable RESA screening method presented in this study may revolutionize the screening of hearing-impaired adults in Denmark and potentially also in other developed countries comparable to Denmark.


Over-the-counter hearing aids have been available to consumers in the US since 17 October 2022 following a ruling by the Food and Drug Administration. However, their reception by hearing healthcare professionals (HHP) has been mixed, and concerns have been expressed by many HHPs. The aim of this study was to examine the concerns that HHPs have towards over-the-counter (OTC) hearing aids. The study used a retrospective survey design. The survey data of HHPs (n = 730) was obtained from Hearing Tracker. A 22-item structured questionnaire was administered using a Question Scout platform. Descriptive analyses examined reported areas of concern and a Fisher’s exact test examined the relationship between demographics and responses. A cluster analysis with partitioning around medoids (PAM) was used to identify a sub-group of participants based on responses. Nearly half of HHPs who participated reported that they will support patients with OTC hearing aids purchased elsewhere, whereas a quarter reported that they will sell OTC hearing aids in their clinic or website. HHPs expressed over 70% agreement in ‘concern’ statements in 14 of the 17 items. Issues about safety, counseling, and audiological care were the key concerns expressed by HHPs about OTC hearing aids. Some demographics  were associated with responses to some statements. Two groups were identified based on the responses to concern statements. The HHPs in the first cluster ‘OTC averse’ (51%) agreed on all the 17 concern statements, whereas the second cluster ‘OTC apprehensive’ (49%) had some items rated as disagree  and neither agree nor disagree , and remaining items were rated as agree. OTC hearing aids were initiated to improve affordability, accessibility, and hearing aid uptake and are currently a rapidly emerging category of hearing devices. Overall, the results of the current study indicate that HHPs have serious concerns about OTC hearing aids. HHP concerns cited in this study provide useful feedback to stakeholders  involved in improving OTC hearing aid implementation. Hearing loss is one of the most frequent chronic conditions in older adults with over 430 million people across the globe requiring rehabilitation . HearingOTC hearing aids add to a range of hearing devices in the U.S. market including prescription hearing aids and various direct-to-consumer hearing devices such as personal sound amplification products (PSAPs) and hearables ,8. The OThe availability of OTC hearing aids has already created new service delivery models which can be primarily grouped into three categories . First, Discussion and development of an OTC hearing aid category started over a decade ago following the recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM), President’s Council of Advisors on Science and Technology (PCAST), and the 2009 National Institute on Deafness and Other Communication Disorders (NIDCD) working group . HHPs anThe primary aim of this study was to examine HHP views regarding OTC hearing aids. The secondary aims included understanding how HHP professional positions interacted with their views on OTC hearing aids and identifying sub-group of HHPs based on their views towards OTC hearing aids.The study used a retrospective survey design using an anonymous survey of HHPs on their views towards OTC hearing aids. Institutional review board approval was obtained from the research ethics committee (Reference number 02606623-HUM007/0922) at the University of Pretoria, South Africa prior to data analysis. There was no informed consent as the survey data was not part of a research study, although participants were aware that the data can potentially be used for research purposes.Data was collected by a cross-sectional online survey administered by HearingTracker.com using the Question Scout platform using convenience sampling. The survey link was posted in several audiology Facebook groups and for those audiologists who are registered for audiologist informer newsletters at HearingTracker.com in August 2022, immediately after the FDA ruling was released. The users of this group were encouraged to complete the survey anonymously and no incentive was given to participants. No strict inclusion/exclusion criteria were used. However, all users of this community who were mainly HHPs were encouraged to complete the survey. The survey included a 22-item structured questionnaire of which 17 items were focused on examining the HHPs’ concerns about OTC hearing aids and the remaining 5 questions gathered some basic demographics . The questions on concerns about OTC hearing aids were rated on a 5-point Likert scale , with agreement suggesting a more negative view or concern about OTC hearing aids. These 17 items were grouped into 5 domains that included HPP’s views regarding (a) safety, (b) concerns about device handling and self-adjustment, (c) concerns about service delivery model, (d) concerns about counseling and audiological care, and (e) concerns about the optimal benefit and adverse events. Seven hundred and thirty HHPs completed the survey.Analyses were performed using R software (version 4.2.2). Concerns towards OTC hearing aids for each of the 17 items expressed by HHPs were analyzed using descriptive statistics. Fisher’s exact test was used to examine the relationship between demographic variables of HHPs  and their views towards OTC hearing aids. The unadjusted odds ratio was also calculated and reported. A Fisher’s exact test was performed on each of the 17 items with the two demographic variables, although only significant associations are reported in the manuscript. Finally, cluster analysis with partitioning around medoids (PAM) was used to identify a sub-group of HHPs based on their views towards OTC hearing aids.do not provide good value and consumers will give up amplification) to 4.5 to a few items in the domain of concerns about device handling and self-management  and the domain on concerns about counseling and audiological care . do not provide good value to 93.4% for the item on will not be educated on effective communication strategies. Moreover, for 14 of the 17 items, HHPs expressed over 70% agreement to concern statements. Issues about safety as well as about counseling and audiological care were the key concerns expressed by HHPs about OTC hearing aids. Overall, these results suggest that HHPs have serious concerns about OTC hearing aids.consumers having problems to identify and address common problems, lead to greater confusion, ripped off by bad actors, warranties and return period will be worse, and that consumers will give up on hearing aids. Among audiologists, the odds of believing the following facts: consumers having problems to identify and address common problems, lead to greater confusion, ripped off by bad actors, and warranties and return period will be worse is significantly higher compared to the other HHP professions . Nevertheless, the odds of believing consumers will give up on amplification is significantly higher among business owners.significant safety risk, lead to greater confusion, not benefit as professionally fit hearing aids, do not provide value, and that consumers will give up on hearing aids for practice employees. In comparison with practice employees, the odds of believing significant safety risk is significantly higher in owner category, whereas the odds of believing consumers will give up on amplification is significantly higher in other positions.The current study examined views of HHPs regarding OTC hearing aids by asking them to rate statements relating to several potential areas of concern. In addition, the study examined the relationship between responses and key demographics  as well as identifying sub-groups of HHPs based on their OTC hearing aid-rated concerns. The key results are discussed below.safety, counseling, and audiological care. This is interesting in light of the fact that nearly half of HHPs reported that they will support patients with OTC hearing aids purchased elsewhere and a quarter reported that they will sell OTC hearing aids in their clinic or website. Many HHPs have been preparing for OTC hearing aids by moving from bundled pricing  to unbundled pricing (which differentiates prices for services vs. hearing aids) [Perspectives of key hearing health stakeholders such as HHPs are important for the successful implementation of new and emerging service delivery models for OTC hearing aids. In the current study, the majority of the participants expressed concerns in almost all domains examined but particularly in terms of ng aids) . Neverthng aids) . Future ng aids) ,15, selfng aids) , outcomeng aids) ,19,20,21OTC hearing aids cause safety risks, audiologists are likely to believe that consumers will have problems to identify and address common problems and lead to greater confusion, and business owners are likely to believe that the consumers will give up on amplification. These findings are interesting and demonstrate that concerns of each sub-group of HHPs are likely relevant to the key focus of their profession and primary position. Moreover, the study also examined users based on their responses to the 17-item questionnaire using cluster analysis which identified two sub-groups. The first group  had concerns about OTC hearing aids in all the items, whereas the second group (OTC apprehensive) had neutral or positive views on some items. However, there was little variation between these two groups further highlighting that HHPs participating in this survey tended to have significant concerns regarding OTC hearing aids. These findings need immediate attention as a recent study showed that although the audiologists in the U.S. have low burnout rates, concerns about OTC hearing aids were associated with stress ratings [This study showed associations between demographic variables such as profession  as well as primary position  with some survey items. In particular, practice employees are likely to believe that  ratings . EffortsOur study is one of the first large-scale surveys to highlight HHP concerns regarding OTC hearing aids. On the other hand, consumers may also have concerns about OTC hearing aids. A recent study examined consumer attitudes regarding the changes to U.S. Hearing Healthcare . In thissignificant safety risk, lead to greater confusion) which may have biased HHPs’ responses to those items. Moreover, qualitative methodology may have been more appropriate to gather deeper insights to participants’ perspectives rather than a quantitative questionnaire study. For these reasons, the results must be viewed with caution and as tentative until further studies confirm these findings. Future research should focus on examining the contextual facilitators and barriers to OTC service delivery models according to stakeholders such as users, HHPs, patient organizations, managers of the health systems, companies manufacturing and distributing OTC HAs in different settings. Consideration of potential payers such as insurance companies is another area of future exploration.This is the first large-scale study to report the HHPs views on OTC hearing aids to the best of our knowledge. However, the study had several limitations. First, the recruitment strategy used  may have resulted in sampling bias. Second, to keep the survey anonymous, some key demographic information such as age, sex, years of practice which were vital to generalizing the study results. Third, as the study used a retrospective design, there was no opportunity for researchers to contribute to the survey development and include questions that may be more neutral. Some questions were vaguely worded . Moreover, the sub-group analysis highlighted that over 50% of HHPs are strongly opposed to OTC hearing aids and failed to have neutral or positive views on any item about concerns. The underlying reasons for HHP concerns and their validity should be explored by future studies. Given that OTC hearing aids are a rapidly emerging category of hearing devices, the HHP concerns cited in this study provide useful feedback regarding practical implementation solutions for stakeholders involved in improving and optimizing OTC hearing aid implementation.OTC hearing aids were initiated as a category with the view to improving accessibility and affordability of hearing health care. However, the results of the current study suggest that HHPs have serious concerns about OTC hearing aids (e.g.,


Early identification of mild hearing loss has resulted in early hearing amplification without adequate evidence of effectiveness. This paper describes learnings from a pilot trial, combined with a qualitative study, to highlight the importance of community engagement in designing research studies to determine whether early amplification benefits young children with bilateral mild hearing loss.PART 1 of the study is a proof-of-concept non-blinded multi-centre randomised controlled trial (RCT) of hearing device fitting vs. no fitting aimed to gather preliminary data and determine its acceptability/feasibility in children <2 years old with bilateral mild hearing loss.PART 2 is a qualitative study to understand the barriers/enablers to RCT participation. Of 40 potentially eligible families, nine (23%) declined, three were uncontactable (7%), 26 (65%) ineligible: of these, nine (35%) did not meet hearing threshold inclusion criteria, 11 (42%) were already fitted or had made decisions on fitting hearing device, two (7%) had conductive loss and four (16%) were ineligible for other reasons. Two of 11 (18%) eligible families were randomised. With the limited sample size, outcome measures were not compared between groups. Both participants completed the trial, reported the RCT to be acceptable, and neither changed group post-enrolment.Whilst recruitment uptake could potentially be increased by altering the eligibility criteria, better communication with and reimbursement of clinicians as recruiters, and improving awareness of the study amongst external stakeholders, the RCT methodology does not conform to family-centred practice, and potentially raises ethical concerns regarding potential adverse consequences of not offering early amplification. Parental perception of losing control over choice of management due to randomisation is not an easily modifiable factor. Alternative methodological approaches without randomisation are required to determine whether hearing amplification benefits infants with mild hearing loss.Clinical Trial Registration: identifier [ACTRN12618001608257]. While UEarlier detection has led to improvements in outcomes for children with moderate or greater degrees of hearing loss , 4–7; hoA recent study of 5–7-year-olds with mild hearing loss found that full time hearing device users performed significantly better on grammar and vocabulary measures than non-users, but found no difference in articulation or speech perception . Other rIn the past, clinical management of mild hearing loss has relied on auditory considerations about deprivation and assessment of developmental progress in post-lingual children . More reEvidence on the effectiveness of early hearing device fitting in infants and pre-lingual children with mild hearing loss is therefore needed to guide management of these children, especially in the face of healthcare costs and potentially significant burdens for these families and society. We attempted to answer this research question through a proof-of-concept RCT aimed to gather preliminary data, to be used towards planning for a possible future more definitive RCT, to compare, in children less than 2 years old with bilateral mild hearing loss, language outcomes of those fitted with hearing devices vs. those without hearing device fitting, 6 months post-randomisation. The secondary aims were to collect 6 months post-randomisation data on child social abilities, functional performance and listening effort, parental morale, parent-child relationship and quality of life, as well as determine the acceptability and feasibility of the RCT. However, as our trial failed to recruit sufficient participants, we engaged clinical audiologists and families of young children with mild bilateral hearing loss to conduct a qualitative study to understand the barriers/enablers to RCT participation (PART 2). This paper overall aims to describe our learnings from both the RCT and the qualitative study to highlight the importance of community engagement to help develop the impetus, design and implementation of future research studies to determine whether early amplification benefit young children with bilateral mild hearing loss.2.2.1.Here, we describe the essential details of our trial's recruitment methodology in the context of an unsuccessful trial from which key lessons were learnt. The RCT is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12618001608257); the full protocol is available on the ANZCTR website. The study has ethics approval from the Royal Children's Hospital Human Research and Ethics Committee HREC 38112 (HREC/45275/RCHM-2018-151266).We set out to conduct a proof-of-concept non-blinded multi-centre RCT comparing hearing devices (intervention) with no hearing devices (control) in children less than 2 years old with bilateral mild hearing loss (21 to 40 dB HL) across at least 3 octave frequencies between 250 and 4000 Hz by objective or behavioural testing. Recruitment occurred in three states in Australia: Victoria (VIC), New South Wales (NSW) and Queensland (QLD). Children must have met all of the following criteria to be enrolled in the study: (a) born in VIC, NSW, or QLD and eligible for services of Hearing Australia , (b) less than 2 years old, (c) had parents/carers who spoke English adequately to give consent, (d) had, within the last 3 months, been confirmed to have bilateral mild hearing loss (21 to 40 dB HL) across at least 3 octave frequencies between 250 and 4,000 Hz by objective or behavioural testing, and (d) had pure sensorineural hearing loss. Children with any of the following criteria were excluded from the study: (a) families who had already made a decision of fitting/not fitting hearing devices for their children, or children who were already fitted with hearing devices, (b) complex medical problems/major disabilities , (c) any conductive hearing loss, (d) hearing threshold of <21 dB or >40 dB HL at any frequency, (e) medical contraindication to hearing device fitting, and (f) families who definitively planned to move, during the following 6 months, to a location where follow-up assessment was not possible or practical.Six months after the study started, in response to the poor recruitment rate, inclusion criteria for hearing thresholds were broadened to the following: had, within the last 3 months, been confirmed to have bilateral mild hearing loss  by objective or behavioural testing. That is, children with three- or four-frequency average threshold of <21 dB or >40 dB HL were excluded.The study was conducted at Hearing Australia clinics in the three states from 1st February 2019 to 31st January 2020. At enrolment, the participant child was randomised to either intervention or control. Children in the intervention group received hearing devices as per standard Hearing Australia protocol, and were followed up for hearing device compliance  over 6 months. They also received normal audiological care and parental support as clinically required following Hearing Australia protocol over 6 months, including assessments and clinical counselling by a Hearing Australia audiologist regarding hearing devices fitting, fitting adjustment and follow up appointments at the Hearing Australia centre . Timing The randomization methodology, primary and secondary outcome measures are available from the ANZCTR website and are not reported here as they are not the focus of our learnings in this paper. The feasibility of the RCT was measured by the: (a) number of children enrolled as a proportion of eligible children; (b) number of children who dropped out as a proportion of enrolled children; (c) number of children who changed treatment group from original treatment allocation, as a proportion of enrolled children; and (d) device use—measured by automated data logging in hearing devices over 3 months, and monthly parent report on proportion of device use during waking hours over the last week, during the 6 months after fitting. The acceptability of the RCT was measured by parent-report at the 6 month follow-up through survey with the following questions: (a) “How do you feel about your child being allocated to the hearing aids group vs. the no hearing aids group?”, (b) “Overall, do you feel your child has been advantaged or disadvantaged by being assigned to a fitting or no fitting group?”, and by free text responses.We had estimated our expected sample size according to the known incidence of mild bilateral hearing loss ; approx2.2.Subsequent to determining the feasibility of the RCT, a qualitative study was undertaken to explore the factors that influenced parental uptake of the RCT. This qualitative study received ethics approval (as above). Over a four-month period from June 2020 to September 2020, we invited caregivers who met the same eligibility criteria for the RCT, but without excluding those who had already made a decision of fitting/not fitting hearing devices for their child, to participate in a semi-structured phone interview and complete a basic demographic child and parent questionnaire via REDCap see . Due to We theorised that factors influencing parental uptake in a RCT worked together to influence the decision-making process, therefore Grounded Theory methodology was applied for analysis of all interviews together. Grounded Theory is an iterative, inductive methodology that results in the generation of a theoretical explanatory process relating to a phenomenon, in this case the parental decision making process . In a siThe same researchers who completed the interviews independently completed initial coding of each interview transcript, and the two researchers discussed areas of discrepancy until consensus was reached on how to complete initial coding of all transcripts. A further six transcripts underwent initial coding and discussion held with the wider research team  to ensure consensus on initial codes before all transcripts were coded. After initial coding was completed, a small group of researchers met  to undergo intermediate coding. Intermediate coding is the process of identifying categories and concepts from the initial codes and beginning to identify relationships between the concepts for a theory to merge from the data. The initial theory on parental decision making to participate in a RCT was discussed with a wider research team  and then refined in the final stage of advanced coding, where the final framework was derived and interrelated concepts were established.3.3.1.Here we report only on the outcomes of recruitment for the RCT in view of the aims of this paper. Forty infants were referred to the study. Fifteen referrals were from VIC, 16 from NSW, and 9 from Queensland. All referrals were from audiologists or the Victorian Infant Hearing Screening Program. No referrals were from ENT specialists or paediatricians. Of the 40 potentially eligible families, 3 could not be contacted, 26 were ineligible and 11 were eligible. Of those eligible, 2 participated and 9 declined .Two infants participated. One was randomised to the intervention “hearing devices” group and the other to the control “no hearing devices” group. Both participants were followed up at 6 months. Follow-up of outcomes concluded by 16th April 2020. The participant characteristics, and the primary and secondary outcomes for each participant, are reported in the •2 out of 11 (18%) eligible participants consented to take part.•Neither of the two participants dropped out of the study.•Neither of the participants changed treatment group from the original treatment allocation.•Device use: The participant parent from the intervention group completed 5 out of 6 monthly surveys on device use. The child was ill during two of the reporting weeks and the parent indicated they were not typical weeks for device use, so these two weeks were excluded from analysis. By parent report, devices were worn on average by the participant for 47% of waking hours on weekdays (3.5 h), and 21% of waking hours on weekend days (1.7 h). This is compared to data logging indicating the participant wore the devices on average 4.6 h (right) and 4.5 h (left) per day over 3 months of the study period.Both participant families filled in surveys about the acceptability of the study. They reported positive or neutral feelings about participating in the study. The intervention family reported feeling positive about their child being allocated to that group and felt their child was “highly advantaged”, commenting that being assigned to the fitting group was “good for his learning development”. The control family felt “neutral” about being allocated to that group and did not feel advantaged or disadvantaged. They commented that they were glad their child “didn’t have the trouble of a hearing aid” but were also “worried that it might have been good for her”. They also indicated they understood the purpose of the study well with the comment “I suppose that's the whole point of the study—we just don't know what's best!”.The following describes the outcomes of the feasibility measures:3.2.3.2.1.Ten caregivers and 11 audiologists completed interviews. 3.2.2.The decision that a parent would ultimately make was the result of a complex interplay of: (1) individual circumstances and beliefs, (2) study design factors, (3) perceived benefits of participation, and (4) perceived costs of participation. These four themes and their corresponding subthemes generated a decision-making framework that was underpinned by a major theme of “parent altruism” that was common across interviews and represented in 3.2.2.1.Overwhelmingly, parents spoke of the challenges they faced when making decisions about hearing amplification for their child. Perhaps unlike parents of children with more severe hearing loss, parents of children with mild hearing loss experienced “overwhelming indecision around whether to get hearing aids” [P401]. Parents felt the need to do the right thing by their child:Family say, “Well just do what”s best for her”, and I was like, yeah, well I'm gunna, but I didn't know what that is [P312].Many parents had experienced high levels of stress making decisions around hearing aid fitting due to the lack of evidence surrounding the effectiveness of fitting hearing aids for this population. As such, a common theme was feeling inclined to participate in the trial for altruistic reasons, or “the general good of everyone” [P201]:When we were trying to make the decision about whether to get aids or not, basically it felt really hard to make the decision because there was no information and there was no studies that were really conclusive. I'd want to participate so that future people could make the decision easier. [P401]jump on anything they can do to help” [A405]:Similarly, audiologists with experience attempting to recruit parents into the trial described how the uncertainty surrounding whether to fit hearing aids would lead parents to act altruistically. Parents would “I found that sometimes they're a little bit easier to recruit only because there's that ‘Do we fit? Do we not fit?’ Some families are like ‘Oh, I’d really love to know. I'd love to be part of this, if it makes that decision easier for somebody else down the track.' [A201]The desire to help future parents was often the first factor mentioned when discussing trial participation. When probed further on their decision-making process, parents would relate their reasoning to this anchoring argument, either reinforcing or weakening the initial desire to participate. This is illustrated in the decision-making overview in 3.2.2.2.During the interviews, parents and audiologists described how a family's circumstances and preferences would influence their willingness or capacity to participate in the trial. Two subthemes were identified: timing of study presentation, and hearing aid preferences.3.2.2.2.1.Recruitment into the hypothetical trial and subsequent randomisation (fitted or not fitted with hearing aids) would have occurred when the child was very young, soon after the diagnosis of hearing loss was made. Consideration of the context surrounding families and their emotional state at this point in time demonstrates how the time at which recruitment is conducted can affect uptake. Parents described how receiving their child's diagnosis was an overwhelming experience. In the early stages post-diagnosis, parents felt bombarded by information, needed to attend multiple appointments, and some struggled to come to terms with the diagnosis:As soon as the diagnostic came through, I received numerous emails with attachments that I can read through the hearing loss. But then like those things to me are—I know it's factual but, still, it doesn't really feel very real to me. [P201]Some parents found the invitation to participate in a study brought the emotions surrounding diagnosis and the decision about providing amplification to the forefront. The timing of study presentation is a factor that likely influenced uptake of the trial:So, I guess there's so many decisions, like so many different appointments and things we go through just to get to this stage and you just had a baby. There's just so much going on. It [participating in research] feels like an extra thing without even starting to think about making that decision, and I guess like we're right now in the decision process of whether to get hearing aids or not and we're trying to get as much information as we can to make that decision. I feel like we're half agonising over the decision… Maybe in like another month I would maybe think about it [participating]. [P401]3.2.2.2.2.Another factor that influenced parent willingness to partake in the trial was attitudes towards fitting of hearing aids. Preferences for fitting or not fitting varied among the interviewees; some had strong preferences either way, and some had no preference or had not yet made up their mind. One parent described how participating in the trial would make her feel anxious about her child's development:I think my major thought process would be I'm someone who's very for hearing aids. So, my thought process would be—if he was chosen not to have hearing aids, would that impact his language or development in the future and things like that? I've always put it as if there was a gap or a little stone missing in your steppingstones, if I can replace that for my son I will. So, yeah, it would probably be quite anxious for me. I don't think I would actually join something like that, just in case we were picked to not have them, because I wouldn't want any negative effects on his development or hearing or language. [P405]Somewhat unexpected was that even when parents had strong preferences for fitting or not fitting, this did not necessarily mean they would decline participation in the trial. One parent (who had decided against hearing aids for her child) described how her personal experience of hearing loss had influenced her preferences for her daughter:Well for me being hearing impaired, like it's a little bit confronting to see your daughter with hearing aids and knowing that the stigma around wearing hearing aids at times with other kids and other people that don't really understand. [P203]that it's for the purpose of the study” [P203]. This highlights the importance of ensuring that parents have a good understanding of the purpose and benefits of a study and its design.However, this parent suggested that she would not decline to participate and would not be disappointed being randomly selected for the fitted group as she understood “3.2.2.3.This theme speaks to the challenges faced by researchers when attempting to strike a balance between ensuring that a study design can answer a research question using the highest possible level of evidence, whilst simultaneously maximising participation rates. The responses from parents and audiologists demonstrate that researchers should have clear reasons for the choice of study design, and this reasoning should be made available to recruiters as well as to participants. The researcher conducting the interviews noted that for parents without a background in research or experience participating in trials, the nature of a randomised control trial was understandably foreign. This theme has four subthemes, (1) being a “guinea pig”, (2) randomisation aspect and removal of choice, (3) age of child and study time frame, and (4) clinicians as recruiters.3.2.2.3.1.A common concern voiced by parents was that their child would be participating in something where the outcome or long-term effect was unknown:I do think people usually have a tendency of being scared of trying to do things like this. Like, they feel a bit like they're guinea pigs, I would say. Like, why should I partake in an experimental study, or why should I kind of put my information, all that, out there? [P311]Thinking about it from a child's perspective, realistically they're like a guinea pig, using them—will this work, will that not work, how is this going to affect them, will it not affect them at all? [P405]Parents stated that the complex nature of the study design and the uncertainty could have an impact on parental uptake:Clearly a lack of knowing… the lack of knowledge, like, of knowing what the study is and what the whole process is, would probably make other people around parents suggest not to, not to do it. [P311]When parents had a good understanding of the importance of the research, and indeed the benefits that a randomised control trial design can give, they were more supportive:My husband and I, we're both scientists and we kind of know that research and studies like this are needed to find out things that are going to help people and the greater good. [P203]3.2.2.3.2.Perhaps the most pertinent study design factor that parents and audiologists commented on was the randomisation into the fitted and non-fitted group. Hearing aid preferences varied across interviewees, and it seemed as though some parents were not comfortable having the decision regarding devices taken away. In addition, it raises a potential ethical concern with not providing amplification for these children when failure to do so could potentially negatively impact communication development:You're basically signing up to get the decision taken off you. It feels a bit scary. Like you might be doing the wrong thing by your kid if you got allocated not and your child might be six months behind if they don't have them, but they actually needed them… I guess if I had to commit to a decision for six months, I wouldn't want it to be random, so I probably wouldn't take part in it [P401].Audiologists also noted that some parents were not comfortable with randomisation:When you're doing these random assignments I know that some parents don’t like that because it's taking the control away from them [A202].One audiologist suggested that for parents who were undecided or struggling with the decision surrounding hearing aids, the removal of choice can be positive:I found it especially helpful offering a research project or trial like that, offering it to the families that were very undecided, those that were really in two minds. They had absolutely no idea which way they were going to go. This [participating in trial] meant that they didn't have to decide. It was kind of decided for them [A400].3.2.2.3.3.only six months” and they could go back to their original decision about hearing aids or change their mind after this period [P203]. Similarly, a number of parents thought the impact of participation would be minimal due to their child's young age:Another factor influencing participation in an RCT was the relatively short time frame of the study, and the age requirement. Parents generally felt comforted that their participation would be “Because I still think at his early months—he's only not even three months—to have without the hearing aids for a period of up to six months, it probably won't hurt him that much as compared to when he is two years old, three years old or at school age. [P201]One parent suggested six months was a long period of time, and that the commitment could “become a bit of a burden” (401). However, the opportunity for closer monitoring of the child's development was a strong benefit to participation for this parent, and it would factor in to whether she would agree to participate:I guess if you're involved your child's got more touch points and getting more monitoring that could help identify if there was an issue because I'm assuming if it was identified that he really was not hitting milestones, it'd be easier… I guess people checking in on him and seeing how he's progressing. [P401]As will be discussed in the following theme, the support of audiologists for the study design would be important in this context since clinicians were recruiting families. Some audiologists voiced their concern over the study design:It's good in that it's not a huge length of time to commit to. I don't know how much difference six months would show given they are quite young and they are still so close to the parents and all that kind of stuff. So I don't actually know if it would be long enough to show any significant differences or not [A201].3.2.2.3.4.Due to the relationship with the hearing service provider, audiologists working clinically were tasked with recruiting participants into the study. This could be more effective or beneficial than researchers as researchers are unfamiliar to families, and would not attain as high level of trust as clinicians for facilitating the informed consent process. However, having someone outside the research team responsible for recruitment adds further complexity to the factors that can influence parental uptake of a trial. Like parents, audiologists were generally supportive of the research because they had experienced the challenges of providing recommendations without definitive evidence:I think it would give clinicians more confidence in knowing which way to advise parents about the benefits of amplification vs. non-amplification, or any kind of intervention, I guess because right now it's really hard. I find it very difficult to sort of know what to say to parents [A300].there's a lot to fit into that appointment time” [A403]. Some would simply forget to recruit, “because in the middle of a diagnosis that's the last thing on your mind” [A300], and others spoke of recruitment potentially undermining the recommendations they were making:Nevertheless, audiologists have a relatively short time with families and were justifiably focused on their main responsibility of providing family-centred clinical care. As one audiologist put it: “So if I'm having difficulty convincing them to go through with various recommendations, I would probably not add ‘And would you like to participate in a study?’ into the mix either, and because I think it undermines the recommendation. It's like ‘I’m recommending that you go and get some hearing aids, and by the way, we don't really know yet whether it's going to make a difference.' It's like, yeah, maybe not. [A310].Audiologists had the best interests of the family in mind, and wanted to make sure that participating in the trial would benefit the family:I think either way just being involved with the study, I'd be happy with that because I know that even the children that were randomly allocated into the unaided group, they still received ongoing reviews and speech assessment at certain periods. So, they weren't necessarily just left with nothing. [A400]It was clear that utilising clinicians as recruiters meant that audiologists had to balance their clinical role with their recruitment responsibility. Clinicians have the benefit of knowing how the family is coping with the diagnosis and other priorities in their life, and some stated they would select which families they would attempt to recruit based on how they were “managing the news and the diagnosis” [A310]. Most, however, were of the view that they generally “wouldn’t deny anyone the knowledge of the research” [A309]. Unlike a member of the research team, clinicians may not always prioritise recruitment, particularly if they had less understanding of, or experience with, research:I think that because I have worked in research before I have an appreciation of the benefits of research as well as the challenges of recruitment. So I feel like most other audiologists wouldn't probably give as much energy to this sort of thing as I would. I would probably be more pro supporting research than the general audiologist, and I would find the time, but I don't think that a lot of other audiologists would [A403].Our paper highlights the importance of community engagement in designing and conducting research to determine whether early amplification benefits infants and young children with bilateral mild hearing loss. Important lessons have been learnt from the failure of recruitment for our proof-of-concept RCT. Our subsequent qualitative study explored the barriers and enablers of participation in a RCT, and identified useful concepts that could be applied to future research studies that attempt to address the research question.Over one year from 1st February 2019 to 31st January 2020, 40 infants were referred to the RCT, which was much fewer than expected. During this period, according to data from hearing screening programs and diagnostic audiology services, approximately 146 children were diagnosed with bilateral mild hearing loss in the three states; therefore, only approximately 27% (40/146) were referred to the study team. There were a few possible reasons for why 106 infants were not referred to the study. First, and anecdotally the most common reason, diagnostic and rehabilitation audiologists indicated that they did not refer families to the study if they did not meet the audiology threshold criteria . Second, a database error in Victoria accounted for 9 potentially eligible families missed from being referred. Third, audiologists indicated that they did not refer families if families had insufficient English to give consent.Of the potentially eligible participants referred, the majority were ineligible . The main reason was infants not meeting the hearing threshold criteria. Our inclusion criteria depended upon the infant meeting particular thresholds of hearing loss over three or four frequencies in two ears. Infants may be diagnosed with bilateral mild loss, but even if a single hearing threshold in one (or both) ears changed on subsequent testing, they may have been assigned a different degree of loss. These infants would then have become ineligible for the study. This reflects the fact that diagnosis of mild hearing loss can be uncertain and challenging, and often requires multiple diagnostic audiology appointments to confirm the hearing status . ConversThe other main reason for ineligibility was the infant having already been fitted with hearing aids , or the family having already made the decision to fit or not fit hearing aids , at the time when they were approached by the researcher. Nine out of 11 eligible families declined to take part . Parents did not want their child's treatment decision to be randomised, or did not want to be involved in research. The high ratio of families who declined compared to those who participated indicates that there may have been considerable barriers to participation, and could possibly reflect parents' preference to make their own choice in hearing device fitting. There are many possible reasons for this: parents may feel empowered to take action for their child's hearing loss by fitting hearing aids; parents may perceive benefits to hearing device fitting; and parents may feel potential guilt of denying the child the opportunity to access a full range of sounds, especially if the child has subsequent language delays . These fThere may also be other reasons why we received a lower than expected number of referrals for the study. Some of the families may not have been referred because they did not speak sufficient English to provide consent. In Victoria, around 24% of families of children with congenital hearing loss are culturally and linguistically diverse; the exact proportion of families who do not speak sufficient English is not known . It is also possible some children with complex medical needs were not referred. In an audit of a Victorian clinical service for children with hearing loss, nine out of 129 (7%) of children with mild hearing loss had complex medical needs  of the study. The benefits of utilising clinicians as recruiters are many; however, it is important that researchers consider the burden they may be placing on busy professionals. In particular, we note that no ENT specialist or paediatrician made a referral for study recruitment. Many RCTs rely on clinicians as recruiters, with up to 50% failing to recruit target numbers . A 2013 Our study's greatest limitation was the inability to recruit sufficient participants for the RCT. Its strength was to use qualitative methodology to identify factors influencing participation in a RCT on hearing device fitting in infants with mild bilateral hearing loss, and in so, engaging the community in future study design. This research question is not answerable through a RCT design as the removal of parental choice through randomisation may not align with family centred practice. Therefore, alternative methodologies must be considered. These may involve novel methods of measuring infants’ ability to hear , anIn conclusion, our attempted trial highlighted many barriers and challenges around trial recruitment involving randomisation for families at a very vulnerable and stressful time of their children's lives, shortly after their hearing loss diagnosis. Community engagement is paramount in designing and conducting research to determine whether early amplification benefits infants and young children with bilateral mild hearing loss. Important lessons have been learnt from the failure of recruitment for our proof-of-concept RCT. Better engagement of audiologists as recruiters, and additional supports for parents, may be necessary to improve recruitment rate in designing future studies. However, the RCT methodology takes away caregiver choice and control, may not align with family centred practice and may present a potential ethical concern for future adverse consequences if early amplification is not offered. Alternative research methodological approaches without randomisation are ultimately required to answer the important question of whether early hearing amplification benefits infants with mild bilateral hearing loss.


Clinical findings on cartilage conduction hearing aids (CCHAs) have gradually become clear; however, few reports include a large number of cases. This study included 91 ears from 69 patients who underwent CCHA fitting in our hospital. Their ears were divided into six groups  according to their clinical diagnosis and type of hearing loss. Most clinical diagnoses were aural atresia or meatal stenosis . The purchase rate of CCHAs was higher in the closed-ear group . In the bilateral closed-ear group, air conduction thresholds at 1000, 2000, and 4000 Hz and aided thresholds with CCHAs at 4000 Hz were significantly lower in the purchase group than the non-purchase group. No significant difference was observed between the purchase and non-purchase groups in the unilateral closed-ear group. In the bilateral closed-ear group, air conduction thresholds and aided thresholds were associated with the purchase rate of CCHAs. In the unilateral closed-ear group, factors other than hearing might have affected the purchase rate of CCHAs. Cartilage conduction hearing aids (CCHAs) are a new type of hearing aid. Hosoi found that an unmistakable sound can be heard when a vibration signal is delivered to the auricular cartilage using a transducer, a process which was termed “cartilage conduction” . Hosoi aThe study included 91 ears from 69 patients  who underwent CCHA fitting in our university hospital between December 2017 and December 2022. To examine the effect of CCHAs on closed ears clearly in this study, we excluded ears on which meatoplasty had been performed. Cases with aural atresia or severe canal stenosis were recruited into bilateral or unilateral closed-ear groups. Cases with chronic otitis media or chronic otitis externa with otorrhea who experienced difficulties with ACHAs were recruited into the continuous otorrhea group. Other diseases were divided into three groups  according to the type of hearing loss.Pure-tone audiometry was performed on patients aged 6 and older using an AA-78 diagnostic audiometer . Behavioral audiometry was performed on patients aged 2 to 5 using an AA-73 diagnostic audiometer (Rion). These tests were performed in a soundproof compartment, primarily on the patient’s first visit to our hospital. Air and bone conduction audiometric measurement thresholds were calculated for each ear at 250, 500, 1000, 2000, and 4000 Hz. The air and bone conduction threshold averages were calculated using five averages .HB-J1CC and HB-A2CC CCHAs (Rion) were used for CCHA fitting. When patients tested the CCHAs, a double-sided skin tape  was used to fix the transducers to the tragal area, which consists mostly of cartilage. The position of the transducers was similar to that of previous reports ,16,17. AThis study was approved by the Ethics Review Committee of the Nagoya University School of Medicine, Nagoya, Japan (No. 2022-0492).X2 test. Air and bone conduction thresholds, aided thresholds with CCHAs, and mean ages were compared between CCHA purchase and non-purchase cases using the Mann–Whitney U test. Comparisons between aided thresholds with previous hearing aids and those with CCHAs were also assessed using the Mann–Whitney U test.The IBM SPSS Statistics software  was used for statistical analyses. The significance level was set to 5%. The sex distribution and presence of previous hearing aids were compared between the two groups using the Patients bought CCHAs for a total of 47 ears. Forty-two of these ears suffered from aural atresia or severe canal stenosis . The remainder included an ear with chronic otitis externa with otorrhea , an ear with mixed hearing loss , and three ears with conductive hearing loss . The purchase rate for sensorineural hearing loss was 0%. In the unilateral closed-ear group, patients whose opposite ear’s hearing level was more than 30 dB had a higher purchase rate than those whose opposite ear’s hearing level was less than 30 dB. (100% vs. 58.3%). In the four purchase cases with mixed or conductive hearing loss, all four opposite ears suffered from conductive hearing loss. Three patients chose CCHAs for cosmetic reasons and refused to try the ordinary behind-the-ear type of ACHA. Another patient, whose opposite ear had severe canal stenosis, chose CCHAs because he wanted to use the same hearing aids bilaterally. We focused on the closed-ear group because both the number of ears and the purchase rate were high.To observe the effect of CCHAs on unilateral aural atresia or severe canal stenosis clearly, we performed a comparison between CCHA purchase and non-purchase cases in unilateral closed ears whose opposite ear’s hearing level was less than 30 dB . The meaIn this study, we investigated 91 ears that underwent CCHA fitting in our hospital. The number of ears and the purchase rate were high in the closed-ear group, as reported previously ,17.Patients with bilateral closed ears usually require hearing aids ,22,23. TPatients with unilateral closed ears often have another ear with normal hearing and do not consider hearing aids to be essential. On the other hand, the negative effect of unilateral severe hearing loss on communication, development, and education has been reported ,27, and The purchase rate in the continuous-otorrhea group was lower than that reported previously ,17. All It is necessary to consider the possibility that hearing aid prices influence hearing aid purchases. One HB-J1CC CCHA costs JPY 300,000, and two HB-J1CC CCHAs cost JPY 510,000. One HB-A2CC CCHA costs JPY 350,000, and two HB-A2CCs cost JPY 600,000. In this study, most previously used BCHAs were Mini Digital BCHAs  fixed with hard headbands. One Mini Digital BCHA costs JPY 189,000, and two Mini Digital BCHAs cost JPY 346,000. ACHAs range from cheap to expensive, but some behind-the-ear types of ACHAs can be purchased for JPY 100,000 to JPY 200,000 per unit. CCHAs and some behind-the-ear types of ACHAs are sold at special prices for those under 20 years of age. In Japan, one HB-J1CC CCHA costs JPY 150,000, and two HB-J1CC CCHAs cost JPY 300,000. One HB-A2CC CCHA costs JPY 175,000, and two HB-A2CCs cost JPY 350,000. Some behind-the-ear types of ACHAs cost approximately JPY 43,900 in special cases. Meanwhile, Mini Digital BCHAs are sold at the same price regardless of age. These prices can be summarized as follows: for those over 20, ACHAs and BCHAs are cheaper than CCHAs. For those under 20, ACHAs are also cheaper than CCHAs. However, the price of BCHAs is not much different from that of CCHAs. In this study, two-thirds of patients who tested CCHAs were under 20, and those who used BCHAs might have been more likely to choose CCHAs from an economic point of view.There are some limitations to the present study. The purchase rate could be influenced not only by the attainment of suitable aided thresholds, but also by considerations of aesthetics, comfort, and the economic dimension. The purchase rate is not a pure measure of CCHA effectiveness. Meanwhile, when considering which patients should be recommended for CCHAs, it is good to focus on the purchase rate, as their appearance, comfort and economic advantages are also considered when they are compared with BCHAs, which are often competitive. Due to the examination taking place in only one facility, regional factors, such as subsidies by local governments, might have affected our results. We used data from a relatively early sales stage; therefore, purchase trends may change in the future. Further investigations are required.The purchase rate of CCHAs was particularly high in ears with aural atresia or severe canal stenosis. In the bilateral closed-ear group, air conduction thresholds and aided thresholds were associated with the purchase of CCHAs. In the unilateral closed-ear group, factors other than hearing might affect the purchase of CCHAs.


Smartphone technology can provide an effective means to bring real-life and (near-)real-time feedback from hearing aid wearers into the clinic. Ecological Momentary Assessment (EMA) encourages listeners to report on their experiences during or shortly after they take place in order to minimize recall bias, e.g., guided by surveys in a mobile application. Allowing listeners to describe experiences in their own words, further, ensures that answers are independent of predefined jargon or of how survey questions are formulated. Through these means, one can obtain ecologically valid sets of data, for instance during a hearing aid trial, which can support clinicians to assess the needs of their clients, provide directions for fine-tuning, and counselling. At a larger scale, such datasets would facilitate training of machine learning algorithms that could help hearing technology to anticipate user needs.In this retrospective, exploratory analysis of a clinical data set, we performed a cluster analysis on 8,793 open-text statements, which were collected through self-initiated EMAs, provided by 2,301 hearing aid wearers as part of their hearing care. Our aim was to explore how listeners describe their daily life experiences with hearing technology in (near-)real-time, in their own words, by identifying emerging themes in the reports. We also explored whether identified themes correlated with the nature of the experiences, i.e., self-reported satisfaction ratings indicating a positive or negative experience.Results showed that close to 60% of listeners' reports related to speech intelligibility in challenging situations and sound quality dimensions, and tended to be valued as positive experiences. In comparison, close to 40% of reports related to hearing aid management, and tended to be valued as negative experiences.This first report of open-text statements, collected through self-initiated EMAs as part of clinical practice, shows that, while EMA can come with a participant burden, at least a subsample of motivated hearing aid wearers could use these novel tools to provide feedback to inform more responsive, personalized, and family-centered hearing care. To overcome such communication barriers, previous research has aimed to define a common lexicon that could be used during hearing rehabilitation by all parties involved. Gabrielsson and Sjögren 1979)  asked li9  asked Recently, smartphone-connected hearing aids have allowed listeners to report on their experiences in (near-)real time, i.e., during or shortly after they occur, by responding to surveys in a mobile application. This type of repeated data collection, also referred to as “experience sampling” or Ecological Momentary Assessment EMA , 16) aim aim16)) Here, we describe a retrospective, exploratory analysis of clinical data, collected through EMA. The dataset consists of self-reported satisfaction ratings (indicating whether a momentary experience with hearing technology was positive or negative) and written open-text statements describing the experiences. Both were provided by real-world hearing aid wearers as part of their hearing care, by self-initiating surveys on a mobile application. Our aim was to explore how listeners describe their experiences with hearing technology, in real-time and in their own words, and identify emerging themes in the reports. Also, we explored whether identified themes correlated with the nature of the experiences, i.e., positive vs. negative self-reported satisfaction ratings. We hypothesized hearing aid wearers to describe perceptual experiences and experiences with hearing technology, with guidance for further fine-tuning, as well as related to practical matters, e.g., in terms of handling of the hearing devices , 14. As 2.2.1.A total sample of 8,793 self-initiated EMAs, provided by 2,301 hearing aid wearers as part of their hearing care, were analyzed retrospectively. The de-identified EMA data was collected through a smartphone mobile application compatible with commercially available hearing aids. No demographic data was collected, other than country in which the hearing aids were adjusted, as well as brand and type of the hearing aids – from which the technology level of the devices could be deducted. All listeners were lawfully informed that their de-identified data could be analyzed for clinical and research purposes upon acknowledging the data privacy notice of the mobile application. Ethical approval was obtained from the Institutional Review Board at Lamar University, Beaumont, Texas, United States (IRB-FY21-252) prior to analyzing the data.2.2.The smartphone mobile application through which the data was collected, was freely available for download in the app store. The particular feature of the app through which the data was collected, was accessible for hearing aid wearers when it was activated by a clinician in the fitting software. Clinicians could choose to activate the feature whenever they believed that the listener and their hearing rehabilitation would benefit from a real-time feedback system, e.g., to highlight situations relevant for further counselling or fine-tuning. Listeners were required to open the mobile application on their own initiative, when they decided that an event of interest took place (self-initiated EMA), and (1) indicate whether they were having a positive or negative experience ; (2) respond to one, sometimes two (depending on the answers provided by the listener) multiple choice questions related to the momentary listening environment and problems encountered in these environments (not considered for this report); (3) optionally, add additional feedback through an open-text field, by describing their experiences in their own words.2.3.An initial sample of 30,127 self-initiated EMAs on real-world hearing aid experiences was collected worldwide between May 2018 and June 2021 and extracted from cloud-based data logging of the smartphone mobile application. The data was preprocessed using R statistical software . As visu2.4.The final sample of 8,793 self-initiated EMAs was analyzed using R statistical software  and IramTo explore how listeners describe their experiences with hearing technology, a cluster analysis was performed on the open text data, in order to identify emerging themes in the reports. The cluster analysis method applied here was a Descending Hierarchical Classification using the Reinert Method , 22. Thiχ2) statistic. Hereby, the χ2-value reflects the association between the rows and columns of a contingency table and χ2/n  the association strength between two categorical variables . For the first split, the algorithm divides the initial matrix into two sub-matrices, which are as lexically different from each other as possible. This is done by minimizing the number of word forms that the two sub-matrices have in common  = 2 (1–4) EMAs per listener) and between 4 and 90 EMAs for 22% of listeners . Most EMAs included in the sample were logged for hearing aids fitted in the United States of America  and Canada , followed by Australia , England , New Zealand , and Ireland . Almost half of the EMAs  were logged for hearing aids with premium technology levels see . Overall3.2.Across the 8,793 text statements considered in this analysis, with one text segment collected as part of one listener self-initiated EMA, a total number of 145,926 word forms and 6,245 different word forms were recorded. About 44% of all individual word forms , corresponding to 2% of the total number of words  were recorded only once.χ2-values.Cluster analysis revealed that 97.9%  of the available text data could be classified into the resulting clusters, indicating that the results are representative of the corpus. The clustering revealed two branches see , one consound quality and speech intelligibility in challenging situations. This branch consisted of four clusters, reported here from largest to smallest:1.Communication and speech intelligibility in challenging situations, containing 21.0% of clustered texts, describing experiences related to conversations and speech understanding in social or acoustically challenging settings, such as restaurants, bars, office spaces, and cars – very often portraying multiple speakers in different locations.2.Noise and naturalness of sounds, containing 13.6% of clustered texts, describing experiences related to the sound quality, and especially naturalness of sounds and different types of (background) noise, such as sounds of wind, air condition, or running water.3.TV experience and loudness comfort, containing 12.7% of clustered texts, describing experiences related to watching TV and especially, volume settings when watching TV.4.Music experience and sound quality, containing 10.8% of clustered texts, describing experiences related to listening to or streaming music, and especially, the sound quality of music – often related to clarity, timbre, and bass or treble volume.The last three clusters were more related to each other than to the communication and speech intelligibility in challenging situations cluster, as revealed by the hierarchy of the bipartitions in the clustering  = 4.79, p = .57). The signs of the χ2 test's standardized residuals inform about the direction of the outcomes, with positive values suggesting a positive relationship, and negative values a negative relationship. As visualized in physical fit & comfort = .75, zbattery = .92, zconnectivity = 1.25). In turn, and as visualized in noise & naturalness of sounds = .09, zmusic experience and sound quality = .49, zTV experience and loudness comfort = .88, zcommunication & speech intelligibility in challenging situations = 1.34). Note that a positive residual, suggesting a positive relationship between a cluster and positive satisfaction ratings, is accompanied by a negative residual of the same size, suggesting a negative relationship between the same cluster and negative satisfaction ratings.A two-sided 4.The aim of this retrospective analysis was to explore the use of written open-text statements, collected through self-initiated, smartphone-based EMAs as part of adult hearing care. In particular, we aimed to identify emerging themes in 8,793 reports of hearing aid wearers, describing daily life, in-the-moment experiences with hearing technology in their own words. We also explored the relationship between the identified themes and self-reported satisfaction ratings (positive vs. negative). Results revealed that almost 60% of listeners’ reports related to sound quality and speech intelligibility in challenging situations. In comparison, close to 40% of reports related to hearing aid management ”, “I unpaired my hearing aids and now I don't know how to pair them again help!!!”, “it would be nice to listen to music off my phone at times like a pair of ear buds. if these do it please let me know how to do it.”, Other reports describe experiences regarding expectations, e.g., “(…) Saw a singer in the pub at night. It was hard to make out what people were saying. Went back to lip reading. Maybe I was expecting more.”, “My first experience in noisy restaurant. They were disappointing. They need to “focus” more on the person speaking. I was about a meter away.”, “wind noise more than I expected when driving my golf cart”. Since this cluster analysis relies on identifying lexical themes based on cooccurring words, other types of analyses might shed more light on person-related themes specifically, such as sentiment analysis or qualitative content analysis .In terms of distribution of reports across the clusters, about one fifth of listeners' experiences presented here were associated with communication and speech intelligibility in challenging situations. Another 37% of reports described elements of sound quality, which were captured in three separate clusters, i.e., noise and naturalness of sounds (13.6% of reports), TV experience and loudness comfort (12.7% of reports), and music experience and sound quality (10.8%). It is indeed known that, beyond speech intelligibility, communication, and sound quality , 39, wat4.1.To our knowledge, this is the first study to report on a large data set of self-initiated EMAs, containing open-text statements provided by hearing aid wearers. It is important to acknowledge that the data explored was not collected for research purposes. The data was logged to support hearing aid wearers and clinicians during the hearing rehabilitation process, i.e., for purposes of counselling and fine-tuning by collecting in-the-moment feedback. Using clinical data for research purposes offers real-world insights that can support continuous improvements in health care  and perssaw a singer in the pub last night (…)”, “I attended an important work meeting with 8 client representatives (…)”. At the same time, it is encouraging that listeners still provided feedback shortly after the event, e.g., when they had time or felt comfortable doing so, as the information could still be valuable to clinicians. Finally, no demographic or audiological information was available for the hearing aid wearers, beyond the hearing aid technology level.A further limitation of this study is that we cannot rule out that listeners self-initiated EMAs retrospectively, once the hearing event was over, thereby still being prone to recall bias. As is apparent from anecdotal examples described in the past tense, listeners might especially describe events retrospectively when they occurred in a setting where phone use is less appropriate, e.g., “5.The use of smartphone technology can provide an effective means to bring real-life and (near-)real-time feedback from hearing aid wearers into the clinic. This first report of open-text statements, collected through self-initiated smartphone-based EMAs, shows that listeners reported experiences related to communication in challenging situations, sound quality dimensions, and hearing aid management. While reports of communication in challenging situations and sound quality tended to be valued positively, experiences related to hearing aid management tended to be valued negatively. Anecdotal examples, further, revealed very detailed reports of daily-life situations, nuances, and interactions with significant others that provide unique insights into integral aspects of hearing care. Thereby, this study illustrates that, while EMA can come with a participant burden, at least a subsample of motivated real-world hearing aid wearers could use their own words to provide valuable feedback to a clinician through self-initiated EMA, to inform more responsive, personalized, and family-centered hearing care. Also, it suggests opportunities for large-scale data collections to facilitate training of machine learning algorithms fostering hearing technology to anticipate user needs.