The objectives of this study were to determine efficacy of hearing aids in older adults using audiology best practices, to evaluate the efficacy of an alternative over-the-counter (OTC) intervention, and to examine the influence of purchase price on outcomes for both service-delivery models.The design of this study was a single-site, prospective, double-blind placebo-controlled randomized trial with three parallel branches: (a) audiology best practices (AB), (b) consumer decides OTC model (CD), and (c) placebo devices (P). Outcome measures were obtained after a typical 6-week trial period with follow-up 4-week AB-based trial for those initially assigned to CD and P groups.Older adults from the general community were recruited via newspaper and community flyers to participate at a university research clinic.Participants were adults, ages 55–79 years, with mild-to-moderate hearing loss. There were 188 eligible participants: 163 enrolled as a volunteer sample, and 154 completed the intervention.All participants received the same high-end digital mini-behind-the-ear hearing aids fitted bilaterally. AB and P groups received best-practice services from audiologists; differing mainly in use of appropriate (AB) or placebo (P) hearing aid settings. CD participants self-selected their own pre-programmed hearing aids via an OTC model.Primary outcome measure was a 66-item self-report, Profile of Hearing Aid Benefit . Secondad). CD service-delivery model was efficacious, with similar effect sizes. However, CD group had a significantly (p < .05) lower satisfaction and percentage  likely to purchase hearing aids after the trial.Per-protocol analyses were performed. AB service-delivery model was found to be efficacious for most of the outcome measures, with moderate or large effect sizes .https://clinicaltrials.gov/ct2/show/NCT01788423Clinicaltrials.gov: NCT01788432; https://doi.org/10.23641/asha.5382499 This report is dedicated to the memory of Dr. Gordon Blackistone Hughes, MD, clinical trials coordinator for the National Institute on Deafness and Other Communication Disorders (NIDCD) from 2008 to 2015. His guidance and assistance throughout this trial were critical to its success and are greatly appreciated by the authors.According to the 2012 National Projections made by the U.S. Census Bureau, about 50 million Americans are over 65 years of age, representing 15% of the U.S. population . ApproxiThe clinical trial described here addressed one of the high-priority research questions identified by the working group and summarized by “What is the comparative effectiveness between two delivery schemes (current best practice vs. others), with technology held constant?” (para. 40);“What is the minimal hearing health care delivery system needed for successful outcomes and quality care?” (para. 40); and“How does an individual define hearing aid value (performance/satisfaction/benefit related to cost)?” (para. 38)As summarized by There are two primary components to the average retail price of hearing aids sold in the United States: (a) the cost of the devices themselves from the manufacturer and (b) the fees for services rendered by the professionals delivering the devices. The production costs of most hearing aids are relatively low, although production costs do not include other costs such as research and development, marketing, technical support, and so on. For example, for the devices used in this project—good-quality devices with multiple-channel compression, feedback cancellation, noise reduction, and directional microphones—the production costs were about $100/aid at study onset. Extremely high-volume dispensers of these devices, such as Costco and the Veterans Administration, were charged by the manufacturer about $250–$500 per aid at that time. Wholesale prices to lower-volume dispensers for these devices ranged from about $900–$1,200, and the average retail price charged by these dispensers for these same aids in the United States was about $2,000–$3,000 per aid at that time. Of course, the difference between the dispenser's wholesale price paid and retail price charged is not all profit. The dispenser too has a variety of business expenses to cover. In part, the mark-up from the dispenser's cost to the consumer's purchase price has been justified on the basis of superior outcomes associated with the audiologist-based service-delivery model. No prior study, however, has documented differences in outcomes between the higher-priced audiologist-based service-delivery model and possible lower-priced alternative service-delivery models, including the over-the-counter (OTC), try-and-select service delivery model.The NIDCD/NIH working group meeting and report sparked broader interest in the accessibility and affordability of hearing health care. The meeting and report provided the impetus for two additional recent influential reports. The first of these two subsequent reports was by the President's Council of Advisors on Science and Technology . This reUntreated hearing loss, especially in older Americans, is a substantial national problem. Only a fraction of consumers who need assistance with hearing obtain and use hearing aids, in large part because of high cost, complex dispensing procedures, social stigma, and performance shortfalls. (p. 1)The PCAST report went on to identify several problems with the classification of current hearing technologies by the Food and Drug Administration (FDA) and with the existing service-delivery systems, advocating throughout the report for a range of technologies and service-delivery models, as well as proposing modification of FDA regulations to parallel those addressing devices for vision problems.Hearing Health Care for Adults: Priorities for Improving Access and Affordability  published a report titled, dability . In the The loss of hearing—be it gradual or acute, mild or severe, present since birth or acquired in older age—can have significant effects on one’s communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them … The unmet need for hearing health care is high. Estimates of hearing aid use are that 67 to 86 percent of adults who may benefit from hearing aids do not use them … This study focuses on improving the accessibility and affordability of hearing health care for adults of all ages … Hearing health care is viewed through the social-ecological model that emphasizes the multiple levels of support and action needed throughout society to promote hearing and communication and reduce hearing loss and its effects. (pp. 1–2)The report then proceeds to advocate for a wide range of technologies and service-delivery models to better meet the hearing-health-care needs of millions of older Americans with impaired hearing. The report recommends strongly that the FDA create a new category of technology, “over-the-counter wearable hearing devices,” with corresponding changes in the ways such devices would be delivered to consumers.Clearly, the OTC service-delivery approach is designed to address affordability by bypassing the additional professional services often bundled with the price of the devices—that is, it is assumed that a hearing aid purchased from an audiologist using the best-practices model of service delivery e.g.,  would beboth the best-practices AB model and the alternative OTC CD treatment can be established  model and an OTC consumer-decides (CD) model. The placebo (P) group received the same services as the participants in the AB group, but the hearing aids were programmed to be acoustically transparent (0-dB insertion gain). Importantly, by inclusion of the placebo group in this trial, the efficacy of ed e.g., . Thus, tThe impact of the purchase price of the hearing aids on outcomes was also evaluated in this trial. The first half of the trial's participants paid $3,600 for their pair of hearing aids, which was considered a typical purchase price at study onset, whereas the subsequent half of participants paid $600 per pair, which was considered a reduced purchase price. Ideally, it would have been preferred to randomly assign the purchase price as well as the service-delivery model, but it was deemed too difficult to do so while maintaining the blinding of the participants and the audiologists with regard to purchase price.Supplemental Material S1) and all data-collection forms . For the complete SPSS raw data file, please contact the corresponding author.In this report, we provide full procedural details and a detailed examination of the results, all based on per-protocol analyses. In addition, the online supplemental materials contain a full copy of the detailed clinical trial protocol  best-practices service delivery, consumer-decides (CD) or OTC service delivery, and placebo (P). The purchase price of the hearing aids provided to the participants was also manipulated: either a “typical” purchase price of U.S. $3,600 or a reduced purchase price of U.S. $600 for both hearing aids. As noted previously, this was done in a stratified manner with roughly the first half of study participants paying the typical price and the second half paying the reduced price.10-frequency-based (warp) compression bands with nine gain handles and four programs available. These mini-BTE open-fit devices are representative of the most popular type of hearing aid sold in the United States to older adults . For the participants in the placebo group, their hearing aids programmed for 0-dB insertion gain, had minor gain variation across programs as follows: Program 1 = +2 dB; Program 2 = +1 dB; Program 3 = 0 dB; and Program 4 = +3 dB. At the 6-week follow-up (Session 3), hearing aid datalogging revealed that, on average, the hearing aids were in Program 1 74% of the time with no significant (p > .10) variations in this percentage across groups.The study devices provided to all participants in the trial were ReSound Alera 9 mini-behind-the-ear (BTE) open-fit hearing aids having 17 logts e.g., . All heats e.g.,  specificts e.g.,  and X = n = 35) and others made use of the default directional microphones . It was unclear whether the loss of some of the front–back localization ability due to a microphone location above the pinna  by phone for an initial eligibility screen and then arranged an initial assessment to make a final determination of eligibility (Session 1). Inclusion criteria were as follows: (a) age 55–79 years; (b) English as native language; (c) Mini-Mental State Exam–2nd Edition . A final determination of eligibility was then made and the Session 1 participant was counseled about the results . Acoustical real-ear-to-coupler differences (RECDs) were then measured for all participants determined to be eligible for the clinical trial. One of two audiologists, A1 or A2, was assigned to complete these Session 1 measures. As shown in the flow diagram in After each participant was consented for Session 1, measures completed were as follows: (a) otoscopic examination of both ears, (b) a complete audiological assessment, (c) MMSE-2 SV, and (d) a detailed case history. Following otoscopy, the audiological assessment began with 226-Hz tympanometry and automated ipsilateral pure-tone acoustic reflex threshold measurement at 500, 1000, and 2000 Hz using a Grason-Stadler Instruments (GSI) Model 39 immittance device. Air-conduction pure-tone audiometry followed, using a calibrated GSI-61 audiometer with Etymotic Research ER-3A insert earphones, at octave intervals from 250 Hz through 8000 Hz plus 1500, 3000, and 6000 Hz. Based on the foregoing inclusion and exclusion criteria, a preliminary determination of eligibility was made at this time. Those determined to be eligible completed the following measures in sequence: (a) speech reception threshold (SRT) for Central Institute for the Deaf (CID) W-1 spondaic words  using mon = 188; see At completion of Session 1, eligible participants for the clinical trial , the first to enroll after screening, was designated by this randomization for assignment to group AB, the second participant (P2) to AB, P3 to CD, … P100 to P. Tallies of group assignments according to this randomization of the first 100 participants needed to be 32–34 participants for each of the three groups. If not, a new randomization list was generated. Once this was accomplished for the first set of 100 participants, a randomization list was then generated for a second and third set of 100 participants in similar fashion. Separate randomization lists were generated a priori for participants in each of the following unaided CST-performance categories: (a) CST ≤ 40%; (b) 40% < CST < 68%; and (c) CST ≥ 68%. The blocking of randomization by baseline  CST performance was necessary because several of the outcome measures included in the trial were relative measures of benefit. It is well known that the amount of benefit measured varies with the initial baseline performance. For example, those with high CST scores at unaided baseline will likely show smaller amounts of aided benefit, whereas those with lower baseline scores will likely show larger improvements when aided. By blocking the randomization based on CST baseline  performance prior to random assignment to groups AB, CD, or P, it was more likely that each group would include a similar number of low, medium, and high baseline CST scores and, therefore, would not bias the subsequent benefit measures derived for each group.Only the CTC and the principal investigator (PI) had knowledge of and access to the randomization lists. The virtual lists were password-protected to prevent access by others on the research team. Once participants were assigned, those assignments were also secured digitally via password protection with hardcopy information secured via a locked file cabinet in the office of the CTC. The PI generated the random allocation sequences, and the CTC enrolled participants and assigned them to groups accordingly.The procedures in Session 2 varied with group assignment. First, for all participants, unaided baseline scores were collected for two self-report outcome measures, the 66-item Profile of Hearing Aid Performance PHAP;  and the 3 coupler) at octave intervals from 250 Hz through 4000 Hz and 94, 97, 99, and 100 dB SPL at octave intervals from 750 Hz through 6000 Hz. Based on the LDLs measured in each ear at 500 Hz and 3000 Hz, the default maximum power outputs noted above may have exceeded LDL for 10% or fewer of the P participants in one or both ears and at one or both frequencies.Next, for the AB participants only, pure-tone sweeps were run at 85 dB SPL to determine if any of these stimuli were uncomfortably loud using the prior LDL rating scale. The audiologist instructed the wearer to quickly raise his or her hand when an uncomfortably loud tone-burst (“beep”) was heard and observed the wearer while the sweep progressed from 250 Hz through 6000 Hz. Affirmative responses resulted in a 4-dB decrease in maximum output for that hearing aid at a frequency aligned with the affirmative response, and the 85-dB sweep was repeated. This process continued until the participant failed to raise his or her hand during a sweep. Once each hearing aid's maximum output had been set individually, both hearing aids were turned on and the 85-dB SPL sweep repeated for final verification of maximum output. Any indications of “uncomfortably loud” sound at this time resulted in a 2-dB reduction of maximum output of both hearing aids. For the 53 AB participants (106 hearing aids), no adjustments in maximum output were made in either ear for frequencies of 250 Hz, 500 Hz, or 750 Hz. The greatest number of adjustments occurred at 3000 Hz, with approximately 25% of the participants requiring adjustment. Of these, for 13 of the 24 hearing aids adjusted at 3000 Hz, adjustments were the smallest possible (4 dB), and only 5 of 24 exceeded two decrements (8 dB). Further adjustments in maximum output when the AB participant was wearing both hearing aids were very rare . Matches to the 65-dB speech targets were not verified again after adjustments to maximum output were made following the 85-dB sweep. Given the low occurrence and small size of maximum output adjustments for the 85-dB stimulus summarized above, together with the nonlinear nature of the programmed output of the devices, it is unlikely that the responses for a 65-dB speech stimulus were impacted by these output adjustments. For the P participants, given the low gain of the devices, maximum output levels were established by entering 0 dB HL thresholds at all frequencies into the programming software  and using the first-fit option to generate the values for maximum power output. This resulted in maximum power output levels of 89, 94, 95, 98, and 100 dB SPL . All participants  also received a written user guide for the hearing aids, which was modified from the manufacturer's guide to include much of this same information.The use of probe-tube-microphone measurements to fine-tune the devices to the hearing aid wearer's hearing loss and the inclusion of hearing aid orientation information, including hands-on practice with these skills, are considered to be to critical aspects of audiology best practices AB; . ParticiFor the CD participants, Session 2 commenced with the CTC escorting the participant to a small room. Containers for the ear tips/domes and tubing to be used—together with three bins containing six hearing aids each, with the hearing aids in each bin differing only in color —were located on a table in this room. Each bin was partitioned into three compartments; each compartment contained a pair of hearing aids labeled X, Y, or Z and programmed in advance to match the NAL-NL2 acoustic output prescriptions for the three most common patterns of hearing loss among older adults in the United States . The thrSupplemental Material S3) overviewing the hearing aid self-selection process, then completed each step of the self-selection process. A hardcopy of the step-by-step instructions was also provided to the participant in the form of three binders, with the contents based on instructions provided for self-fitting hearing aids ; batteries; cleaning tools; and user guide. Payment was also collected at the end of this session. Participants either paid $3,600 with $300 (8.33%) credits for the completion of Sessions 2 and 3, or $600 with $50 (8.33%) credits for the completion of Sessions 2 and 3. The Session 2 credits were applied immediately upon completion of Session 2 and reduced the purchase price to $3,300 or $550. The final credit was disbursed as a check for either $300 or $50 at the completion of Session 3. The participants were not informed about the use of two different purchase prices until the final participant completed all testing. This deception was approved by the Indiana University Institutional Review Board and was necessary so as to assess the impact of purchase price on outcomes. After the final participant had completed the study, those paying the higher price received a letter from the PI and CTC informing them of the deception and a check for the difference in price . Audiologists A1–A4 knew that two different purchase prices were being used in the trial, but they believed this was assigned randomly from participant to participant throughout the study, rather than blocked into two phases. The audiologists, moreover, were blind to the purchase price paid by each participant, as well as the blocking of payment in two phases during the trial, until completion of the entire trial.If any of the participants had problems with their devices during the trial, they were asked to contact the CTC by phone. The CTC initially instructed the participant to review the user guide for assistance. If the participant did so and the problem persisted, and the problem was occurring for just one device, the CTC instructed the participant to remove both devices and compare them to see if anything differed between the two with regard to the tubing, dome, or battery. If the problem persisted, for either one or both hearing aids, the CTC made an appointment for an unscheduled visit. Unscheduled visits began with the CTC performing a visual inspection of the devices. If no problems were apparent, the CTC had the participant remove the devices and contacted Audiologist A1 or A2, whichever one had worked with this participant previously in Sessions 1 and 2. The audiologist first examined the hearing aids and, if nothing was found, next performed otoscopy, tympanometry, or other audiological measures to determine the nature of the problem and remedy it accordingly. The CTC received phone calls from a total of 31 participants between Sessions 2 and 3: 12 from AB participants, 10 from CD participants, and 9 from P participants. Of these, six AB, four CD, and six P participants came in for an unscheduled visit. Most complained of physical discomfort or irritation. Four of the six AB unscheduled visits, three of the four CD unscheduled visits, and two of the six P unscheduled visits resulted in changes to the domes or tubes. In addition, one of the two hearing aids were replaced for one AB participant (lost hearing aid) and one CD participant (broken battery door).M = 44.5 days; SD = 10.1 days), either Audiologist A1 or A2 (the one not involved in Session 2 programming) obtained as-worn aided CST scores and inspected the participant's ears, hearing aids, tubes, and domes, then obtained as-worn electroacoustic performance measures for each hearing aid. An inspection checklist was used to note any issues identified. Following completion of these as-worn measures, the hearing aids were reconditioned as needed  and post-maintenance electroacoustic measures were obtained in the Verifit test box. Next, outcome measures were then obtained by another audiologist, A4. A4 was blind to participant group. The primary outcome measure for this trial was the Profile of Hearing Aid Benefit (PHAB). The PHAB score, a relative benefit measure, is the difference between the unaided and aided scores on the PHAP. The unaided PHAP was administered prior to (Session 2) and the aided PHAP following a 6-week period of hearing-aid use (Session 3), with the difference in ratings on the questionnaire used to compute the PHAB scores. Based on correlational and factor analyses of the seven PHAP subscales , the five communication-related subscales  were averaged to form a PHABglobal score, and the other two subscales  were averaged to form a PHABavds score. The secondary outcome measure to be used in this clinical trial was derived from the unaided and aided CST speech-recognition scores. The secondary outcome measure was based on the difference in aided and unaided CST scores, CST benefit. The aided CST score was based on one passage pair or 50 key words and, like the unaided CST score, was obtained for a speech level of 65 dB SPL and a signal-to-babble ratio (SBR) of +3 dB. The speech level and SBR are similar to those used previously for the CST, including in a randomized clinical trial comparing hearing aids  = 2.28, p > .05. With regard to musical experience or training during the trial, 16%–21% of each group reported singing or playing a musical instrument for at least 20 min twice per week, with no significant differences among the groups, χ2 (2) = 0.50, p > .05.Next, all participants completed the Practical Hearing Aid Skills Test–Revised PHAST-R; , modifieEach participant was then asked, “Now that you've worn these hearing aids for about 6 weeks, are you interested in keeping them?” Their responses were recorded as a preliminary indication of the likelihood that the hearing aids would be retained prior to revealing the group to which the participant had been assigned. Reasons offered in support of their responses were also noted on the response form by Audiologist A4.Next, Audiologist A4 revealed the group to which each had been assigned. For the CD participants, regardless of their preliminary decision about keeping the hearing aids, each was offered another 4-to-5-week trial period with the AB service-delivery, including individual matching of gain and maximum output to the participant's hearing loss and subsequent verification, as well as a hearing-aid orientation session from an audiologist. P participants, given 0-dB insertion gain, were also offered another 4-to-5-week trial period for trial use of hearing aids matched to NAL-NL2 targets and maximum power outputs adjusted as needed. Because no adjustment of the hearing aids' programming took place between Sessions 2 and 3, the AB participants were also offered another 4-to-5-week trial following program adjustment to meet any complaints. Four of 53 AB participants, 49 of the 51 CD participants, and 47 of the 50 P participants who completed Session 3 opted for an additional 4-to-5-week trial at that time.M = 36.2 days, SD = 12.9 days), the procedures described previously for Session 3 were replicated. This is referred to here as Session 3B.The procedures described for AB participants in Session 2 were followed for those in the CD and P groups participating in the additional 4-to-5-week trial, with the exception that those in the P group did not receive a second hearing-aid orientation session. After 4-to-5 weeks  and nonparticipants (N = 24) to see if the study sample may have been biased through this self-selection process.As noted in t tests were conducted for speech-recognition thresholds in the left and right ears, word-recognition scores in the left and right ears, LDLs at 500 Hz and 3000 Hz in the left and right ears, bilateral pure-tone averages , bilateral high-frequency pure-tone averages , unaided CST scores, MMSE-2 SV scores, duration of hearing loss in years, and age. Nonparametric Mann–Whitney U and median tests were also conducted to examine differences in highest education level and annual household income, each of which was a closed-set ordinal measure in this study. Finally, a chi-square test was used to examine differences in gender between the participant and nonparticipant groups. No adjustments were made in the significance levels for multiple dependent variables. Of all the measures in p < .05) from the nonparticipants for only two measures: age and speech-recognition threshold in the left ear. On average, the nonparticipants were 3 years younger and had 5 dB lower speech-recognition thresholds than the participants. We conclude that the unwillingness of the nonparticipants to take part in the trial did not appreciably bias the study sample.t tests, Mann–Whitney U and median tests, chi-square test) were conducted to compare the performance of the 154 participants who completed the trial to that of the nine participants who withdrew after completion of Session 2 for each of the demographic, audiological, and baseline outcome measures. Again, no corrections to the significance level were made for multiple dependent measures. No significant differences were observed, p > .05, between the performance of the 154 participants who completed Session 3 and those nine who withdrew after Session 2. We conclude that the withdrawal of these nine participants did not bias the study sample.Also noted in As noted previously, because we were uncertain how best to implement the placebo devices—with or without directional microphones—we included directional microphones in the first 18 placebo participants. After the next 18 , a comparison was made between the two groups with regard to unaided baseline and aided measures for the primary and secondary outcome measures. No significant differences were observed for the PHAP subscales between these two versions of the placebo treatment, but there were marginally significant differences in aided CST scores with the directional microphone yielding superior performance. Given the configuration of the loudspeakers in the sound field for the target (0-degree azimuth) and competing (180-degree azimuth) stimuli for the CST, this observation was not entirely surprising. Nonetheless, because it was thought that the placebo treatment should not show improvements over unaided performance, especially for objectively measured speech recognition, the remainder of the P participants had hearing aids programmed with omnidirectional microphone function. In the end, there were 20 P participants who had hearing aids with directional microphones, two of whom withdrew between Sessions 2 and 3, and 35 P participants who had hearing aids with omnidirectional microphones, three of whom withdrew prior to study completion. The remaining 18 P participants wearing hearing aids with directional microphones were all in the typical purchase-price subgroup, and 8 of the 32 P participants wearing hearing aids equipped with omnidirectional microphones were in this same purchase-price subgroup (24 in the reduced purchase-price subgroup).p > .05. There were also no significant differences in the average amount of hearing loss  or any of the unaided baselines for the outcome measures , p > .05. Finally, of the primary , secondary (CST benefit), and tertiary  outcome measures, the two P subgroups only differed significantly for the measure of CST benefit, p < .05, with the Pd subgroup demonstrating superior benefit. As noted in p > .05, and better aided CST scores (64 RAU vs. 57 RAU for the Po subgroup), although again not a statistically significant difference, p > .05. The difference between aided and unaided CST scores, or CST benefit, shown in does differ significantly between the two placebo subgroups, as noted above.Based on these analyses of the two P subgroups, the data for the Pd and Po subgroups will be pooled henceforth to represent the P group for all outcome measures. Specifically, for the examination of the factorial combination of the effects of service-delivery group  and purchase price  on outcomes including CST benefit, the data from the Pd and Po subgroups are pooled to represent the entire P group. For CST benefit, this pooling of Pd and Po data increased the mean benefit by about 6 RAU regarding the benefit measured for the Po subgroup .F values < 1.03, p > .05, or price group, both F values < 0.39, p > .05, and no significant interaction between these two factors for either PTA or HFPTA, both F values < 2.59, p > .05. In the initial analyses of the results of this study, a series of general linear model (GLM) analyses were performed with between-subjects factors of service-delivery model  and price group . We began first with evaluation of hearing loss, both PTA and HFPTA, using this 3 × 2 factorial analysis. There were no significant main effects of service-delivery group, both F values all < 0.82, p > .05, and no significant interactions with price group, F values all < 0.42, p > .05. The effect of service-delivery group was not significant for unaided PHAPglobal scores, F = 1.53, p > .05, but there were significant effects of service-delivery group on aided PHAPglobal, F = 27.37, p < .05, and PHABglobal, F = 18.56, p < .05. Post hoc Bonferroni-adjusted t tests revealed that group AB had significantly better (lower) aided PHAPglobal scores than both the CD and P groups, p < .05, and the CD group had significantly better aided PHAPglobal scores than the P group. With regard to the PHABglobal scores, the scores for the AB and CD groups were better than those of the P group, but the AB and CD groups did not differ significantly from one another, p > .05. In general, self-reported benefit for speech communication with amplification is improved for both AB and CD groups relative to the P group.F values < 2.44, p > .05; no significant effect of price group, all F values < 0.85, p > .05; and no Service-Delivery Group × Price Group interaction for any of these three measures, all F values < 0.79, p > .05. Further, these analyses indicated that the PHABavds values (green bars)—pooled across all participants given the absence of any significant effects of service-delivery group, price group, and interaction—did not differ significantly from 0, F = 3.20, p > .05. The aversiveness and distortion of sound changes little from unaided to aided conditions, resulting in near-zero values for PHABavds.F values < 2.19, p > .05. There was no effect of service-delivery group on unaided CST scores, but there was a significant effect on aided CST scores, F = 13.58, p < .05, and on CST benefit, F = 11.78, p < .05. Post hoc Bonferroni-adjusted t tests revealed that this significant effect was due to the P group performing significantly worse than both the AB and CD groups for the aided CST and CST benefit measures, p < .05. With regard to price group, there was a significant effect on unaided CST scores, F = 4.69, p < .05, and on CST benefit, F = 4.79, p < .05, but not aided CST scores, F = 0.26, p > .05. Examination of unaided CST scores obtained prior to enrollment in the trial and subsequent purchase of the hearing aids. Given no differences in aided CST scores between these two purchase-price groups but significantly higher unaided scores for the reduced-price group, CST benefit—the difference between aided and unaided CST scores—is artificially lower in the reduced-price group. When the relative benefit measure, CST benefit, is confounded by seemingly arbitrary price-group differences in unaided CST scores, the measure of aided performance alone, aided CST, might be considered a more appropriate measure of the impact of amplification on speech understanding. Recall that there was no significant effect of purchase price on aided CST scores.F values < 1.90, p > .05, and no significant interactions between price group and service-delivery group, all F values < 1.63, p > .05. There was a significant effect of service-delivery group on aided HHIE, F = 13.90, p < .05, and on HHIE benefit, F = 12.09, p < .05, but not on unaided HHIE scores, F = 0.24, p > .05. Post hoc Bonferroni-adjusted t tests revealed that the AB group had significantly lower (better) aided HHIE scores than both of the other groups , p < .05. No other post hoc comparisons were significant for aided HHIE. For HHIE benefit, the P group showed significantly less benefit than both of the other groups , p < .05, but the AB and CD groups did not differ significantly in terms of HHIE benefit.r = 0.96, p < .05. As a result, the mean of these two values was calculated and represents the average hours of use per day bilaterally. Factorial (3 × 2) GLM analyses on each of these three outcome measures revealed no significant main effect of price group, all F values < 0.72, p > .05, and no significant interactions, all F values < 0.58, p < .05, on any of the three outcome measures. However, a significant effect of service-delivery group was observed for both satisfaction measures, both F values > 6.92, p < .05, but not for daily usage, F = 1.33, p > .05. Post hoc Bonferroni-adjusted t tests revealed that the AB group had significantly higher HASShaf scores than both of the other groups , p < .05, and that the CD group had significantly lower HASSdisp scores than the other two groups .unaided CST performance.As summarized in The remaining three outcome measures in d values for each service-delivery group relative to the P group and for each outcome measure included in this clinical trial. d values of 0.2, 0.5, and 0.8, respectively. Using these labels as a loose guide, medium-to-large effect sizes were observed for both AB and CD service-delivery approaches for the primary outcome measure , the secondary outcome measure (CST benefit), and HHIE benefit. This attests to the efficacy of both approaches to hearing-aid provision examined in this trial. On the other hand, the CD service-delivery model yielded considerably smaller effect sizes than the AB model for measures of satisfaction with the hearing aids' function and features and the daily usage of the devices. This was also true for satisfaction with dispenser-related performance (HASSdisp), but, by design, the CD group did not have interactions with a professional audiologist  and would be expected to be less satisfied with that aspect of the delivery process. Finally, as expected, the effect size for PHABavds was essentially zero and reflects the lack of benefit provided by hearing aids for aversive and distorted sounds regardless of the service-delivery model.The availability of data from the P group enabled the calculation of effect sizes for the two service-delivery models, AB and CD. N = 154) was asked to indicate, based on their experience over the 6-week trial, whether they were likely to keep the hearing aids or return them for a refund. For the AB group, 81% indicated that they would keep the hearing aids, whereas only 55% of the CD group and 36% of the P group planned to keep them . Chi-square testing revealed the AB percentage to be significantly greater than both CD, χ2 (2) = 8.3, p < .05, and P, χ2 (2) = 21.7, p < .05, percentages, but the difference between the CD and P groups was not significant, χ2 (2) = 3.8, p > .05. Of those who were not planning to keep their hearing aids or were undecided at that time, the most frequently cited reason for their response was the lack of benefit provided .At the end of the trial and prior to divulging the service-delivery approach or placebo status of the hearing aids, each participant who completed the trial  = 8.39, p < .05, and follow-up Bonferroni-adjusted t tests showed that the CD group had significantly lower PHAST-R proportions than the other two groups, p < .05, with no other significant paired comparisons emerging. Given the lack of hearing-aid orientation during Session 2 for the CD participants, the poorer performance of the CD group on the PHAST-R is not unexpected.As noted, during Session 3, a slightly modified version of the PHAST-R was completed by all participants. This allowed for a formal assessment of their skills, such as inserting and removing the hearing aids, removing and inserting the battery, cleaning and maintaining the devices, and so on. Points were assigned for each skill by an audiologist (A4) blinded to study group. Points were totaled and divided by the maximum points possible, which could vary slightly from person to person, to yield a proportion of the maximum possible on the PHAST-R. The means (standard deviations) were 0.90 (0.09), 0.84 (0.09), and 0.89 (0.07) for the AB, CD, and P groups, respectively. Analysis of variance revealed a significant effect of service-delivery group on PHAST-R proportions, 2(4) = 4.63, p > .05. Tubing problems, especially twisted or kinked tubing, were the most commonly observed problem, occurring on one or both ears 88% of the time, but there were no differences among groups regarding the frequency of observed tubing problems, χ2(8) = 6.63, p > .05. Weak or dead batteries, on the other hand, were the least frequent problem, occurring 17.5% of the time, with no significant differences among groups in the frequency of these problems, χ2(4) = 1.47, p > .05.When participants returned for Session 3, the blinded audiologist (A1 or A2) first inspected the hearing aids for proper insertion, examined the tubing and the domes, and removed the hearing aid battery and measured its voltage. The number of times a problem occurred was noted for each hearing aid during these Session 3 inspections. Tallies were compiled for the number of inspection problems and then compared across groups. Hearing-aid insertion problems were noted about 36% of the time on one or both sides, but there were no differences among the three groups in the frequency of these problems, χr > 0.70, p < .01, we opted for the SII values at 65 dB SPL for each hearing aid as our global indicator of acoustical function. In addition, CST scores were obtained in Session 3 for both the initial as-worn condition of the hearing aids and also after maintenance and adjustment of the hearing aids by the audiologist. These RAU-transformed scores served as a single-valued metric for functional consequences of these hearing aid maintenance issues. p < .05, than each of the other groups , all F values > 7.22, p < .05. The AB and CD groups did not differ significantly from one another, p > .05, nor was the interaction between group and hearing-aid maintenance significant in any of the three GLM analyses, F values < 1.42, p > .05. In all three GLM analyses, SII values and CST scores obtained postmaintenance were significantly greater than those measured as-worn, F values > 18.6, p < .05. Thus, the hearing-aid maintenance problems observed at the end of the 6-week trial were not inconsequential; rather, they resulted in significantly decreased amplification of speech (SII) and significantly poorer aided speech-understanding performance (CST).Given the high prevalence of various hearing-aid problems, we sought to determine the functional significance of these issues. We had obtained as-worn acoustical measures of each hearing aid in the Verifit test box at the beginning of Session 3 and also had subsequent postmaintenance measures of the same type for each hearing aid. For these acoustical measurements, several gain and output measures were available. Here, we opted to use the aided Speech Intelligibility Index SII;  from the2(4) = 3.87, p > .05. Further, when those who read it were asked to rate the helpfulness of the user guide on a scale of 1 to 10, with 10 = most helpful, the mean (standard deviation) ratings were 7.6 (2.1), 7.0 (2.1), and 7.0 (2.3) for the AB, CD and P groups, respectively. There were no significant differences in these user guide ratings among groups, F = 0.90, p > .05. Overall, all groups tended to use the guides and considered the user guides to be helpful, similarly so across groups.We thought that the CD group, lacking exposure to hearing-aid orientation with an audiologist, might show a greater dependence on use of the user guide or find it to be more helpful than the other two groups who had received such instruction . Approximately 90% of the participants in each group (86.7%–94.1%) indicated that they read the user guide that was sent home with the hearing aids. There was no significant difference in the proportion of each group who did so, χRecall that at the conclusion of the 6-week clinical trial, all 154 participants in Session 3 were informed of their group assignment and offered the opportunity to continue for another 4-week trial period after adjustments to their hearing aids. For the 53 AB participants, five had decided to return their hearing aids at the end of the 6-week trial, four requested adjustments and another 4-week trial period, and the rest purchased their hearing aids. Given the small number of AB participants continuing for another 4-week trial period, these individuals were omitted from any comparisons among outcome measures across Sessions 3 and 3B. For the 51 CD participants, one kept the hearing aids selected for the trial and one returned the hearing aids in Session 3, with the remaining 49 CD participants requesting the additional 4-week trial period before making a final decision. For the P participants, three returned their hearing aids at the conclusion of Session 3 and 47 requested the additional 4-week trial period.One CD participant and one P participant withdrew from the extended trial period prior to completing the measures in Session 3B, but both opted to purchase their devices after adjustment. All 94 remaining participants  received the AB service-delivery model, including real-ear measurements to verify NAL-NL2 targets and individual adjustment of maximum power output. Only the CD participants also received a hearing-aid orientation at this time because the P participants received hearing-aid orientation during the original 6-week trial period.p < .05) paired-sample t tests in each panel. The PHABglobal scores improved significantly for both the CD and P participants after AB service delivery and the extra 4-week trial period. No significant differences were observed for the PHABavds scores. The left-pointing arrows show the mean values for the original AB group from Session 3 for the lefthand outcome measure in each panel, and the right-pointing arrows show the corresponding Session 3 AB values for the righthand outcome measure in each panel. As can be seen, the mean values for the PHABglobal and PHABavds outcome measures obtained in Session 3B from the original CD and P participants following an additional 4-week AB-based trial (gray bars) are very similar to those obtained from the original AB participants (arrows).Also shown in plans to keep the hearing aids after the initial trial. One-hundred percent (17 of 17) of group P and 96% (25 of 26) of group CD who planned to keep their hearing aids after the initial 6-week trial actually kept them at the conclusion of the study. Of those who were undecided after the initial 6-week trial, 100% (14 of 14) of the P participants and 83% (10 of 12) of the CD participants ultimately kept their hearing aids after the additional 4-week trial. Of course, it is unknown how many in the undecided group would have ultimately kept their hearing aids if the study ended at Session 3 and they were forced to make a final decision at that point in time. For those who indicated in Session 3, after the initial 6-week trial, that they did not intend to keep their hearing aids, 80% (12 of 15) of the P group and 60% (6 of 10) of the CD group ultimately kept their hearing aids after reprogramming and an additional 4-week trial.Finally, as was noted, all but a few of the original CD and P group members opted to receive the AB service-delivery and an additional 4-week trial. Recall that at the end of the clinical trial, Session 3, and prior to divulging group membership, each participant indicated whether they planned to keep the hearing aids after the trial. At the end of the extra 4-week trial with AB service delivery, Session 3B, each participant decided whether to purchase the hearing aids. 2 (2) = 0.50, p > .05. For the majority of CD and P participants, however, these retention rates are after completion of the additional 4-week AB service-delivery trial. That is, as noted previously, based on their stated intentions to keep their hearing aids after the initial 6-week trial, the percentage of “yes” responses were 81% (AB), 55% (CD), and 36% (P). Because “undecided” was a permitted response to this Session 3 query, it is impossible to indicate exactly how many of these respondents would have answered “yes” or “no” if forced to choose.At study conclusion, 134 of 154 participants (87%) kept their hearing aids, with small nonsignificant variations in the percentage across initial group assignment , χ2 (1) = 11.26, p < .05.Although initial assignment to service-delivery group had no impact on the percentage of participants who returned their hearing aids, purchase price did impact returns for credit. Whereas roughly half of those who kept their hearing aids paid the typical purchase price (60 of 134 or 44.8%), 85% (17 of 20) who returned their hearing aids had paid the higher typical purchase price. This effect of purchase-price on the number of returns for credit was significant, χThis first-ever placebo-controlled double-blind randomized clinical trial of hearing aids in older adults with impaired hearing demonstrated the efficacy of the audiology best-practices approach (AB) to hearing aid provision. The outcomes obtained for the participants assigned to the AB treatment were significantly better than those obtained from the participants assigned to the placebo group (P). This was true for the primary outcome measure, PHABglobal; the secondary outcome measure, CST benefit; and other tertiary outcome measures as well . Medium or large effect sizes were observed for most of the outcome measures included in this clinical trial. The use of audiology best practices, including the individual evaluation and adjustment of the maximum power output of the hearing aids based on the listener's uncomfortable loudness judgments, did not yield better perception of aversive or distorted sounds (PHABavds) compared to the placebo group. Further, daily usage was not impacted by service-delivery approach.The outcomes obtained by the participants in the AB group were generally positive, as well as being significantly different from the P group. For example, aided speech-recognition performance for sentences in a noise background (CST) was, on average, 21 RAU better than unaided performance. In addition, perceived benefit improved 17–18 percentage points for the speech-communication scales of the PHAB  and a measure of perceived hearing handicap (HHIE). Moreover, the average satisfaction ratings for the features and functions of the hearing aids (HASShaf) for the AB group corresponded to a scale value of “satisfied.” Finally, the AB participants wore their hearing aids for 7 hours per day. Again, all of these results are quite positive outcomes and serve to establish that hearing aids do provide benefits to older adults with mild-to-moderate sensorineural hearing loss.Recall that the CD service-delivery model differed from the AB in two key areas: (a) the AB model made use of real-ear measures to fine-tune the hearing aids to match prescribed NAL-NL2 targets on an individual basis and (b) the AB model included a 45–60 min hearing-aid orientation session. Despite the absence of these two processes from the CD model, this clinical trial also established the efficacy of this simulated OTC service-delivery model. Specifically, the CD group performed significantly better than the P group on the primary outcome measure, PHABglobal; the secondary outcome measure, CST benefit; and on one of the additional outcome measures, HHIE benefit. The CD group, however, demonstrated significantly lower hearing-aid satisfaction scores than the AB group (HASShaf) or both the AB and P groups (HASSdisp). The latter is not surprising, however, given that both the AB and P groups interacted with a professional audiologist during the delivery of the hearing aids, whereas the participants in the CD group had virtually no contact or interaction with a professional during the hearing-aid delivery process. Many of the HASSdisp items pertain to how well the dispenser explained the care and maintenance of the hearing aids, as well as strategies for their use and limitations to their benefits—items covered formally in the hearing-aid orientation by the audiologist for both AB and P participants. As with the AB participants, the CD group did not differ from the other two groups on the measures of perceived aversiveness/distortion of sound (PHABavds) and daily hours of usage.Aside from the inferior satisfaction ratings from the CD group compared to the AB group noted above, a significantly smaller percentage of CD participants than AB participants indicated that they planned to keep their hearing aids at the conclusion of the trial. Moreover, the outcomes obtained from the CD participants after the extra 4-week AB-based trial were significantly higher for the PHABglobal and HASS outcome measures than the results obtained at the conclusion of the trial. Also, 6 of the 10 CD participants who indicated that they were not planning to keep their hearing aids at the conclusion of the original 6-week trial decided otherwise at the conclusion of the extra 4-week AB-based trial. All told, although both the AB and CD service-delivery approaches were found to be efficacious and to yield generally positive outcomes, these additional metrics may give a slight edge to the AB approach over the CD approach.did influence their ultimate decision regarding retention of their hearing aids.The OTC service-delivery approach, one possible version simulated here via the CD model, has been advocated for many years as a way to potentially increase the accessibility and affordability of hearing aids . It was,n = 134) differed significantly from those opting to return them (n = 20). Demographic , audiological , unaided baselines for outcome measures , and MMSE-2 SV cognitive-screen scores were examined. Only hearing loss (both PTA and HFPTA) and age differed significantly between the two groups. Those who returned the hearing aids had less hearing loss and were younger than those who kept them, all t(152) values > 2.6, p < .05. Specifically, mean PTAs (dB HL), HFPTAs (dB HL), and age (years) were 28.9, 39.6, and 69.6, respectively, for the 134 participants who kept their hearing aids and 21.9, 33.0, and 66.0, respectively, for the 20 participants who returned their hearing aids.We examined other variables to see if those retaining their hearing aids . In this case, however, the median audiogram for that subgroup falls between the Y and Z audiograms suggesting that either could be a reasonable match. Finally, a small number  of CD participants appear to have chosen hearing aids (Z) that likely provided considerably more gain in the middle and higher frequencies than recommended by NAL-NL2.We have also examined in more detail the choices made by the CD participants with regard to the hearing-aid frequency-gain characteristics selected for themselves. Examination of the choice of frequency responses based on the NAL-NL2 targets for audiograms X, Y, or Z  revealedRather than rely on the median audiograms for each subgroup of CD participants, we calculated the root-mean-square (rms) error between each participant's audiogram and the X, Y, and Z audiograms used to pre-program the hearing aids. Based on these individual matches, the best-matching audiogram  among the X, Y, and Z alternatives was selected. Based on the comparison of median audiograms for CD subgroups who chose hearing aids X, Y, or Z to the X, Y, and Z audiograms used to program those hearing aids  and the n = 48) and P (n = 46) participants who opted for and completed the extra 4-week AB trial. Several 3 × 2 factorial GLM analyses of the effects of initial service-delivery group and price group on outcome measures failed to find significant effects of service-delivery, all F < 2.23, p > .05; price group, all F < 2.30, p > .05; or their interaction, all F < 1.53, p > .05, on post-AB outcomes for these 147 participants. For service-delivery group, these results are entirely consistent with the visual impression of the data in By study conclusion, there were a total of 147 participants who had completed the AB service-delivery model and provided a full set of outcome measures, 53 original AB participants plus 94 original CD  and in terms of coupling , than the conventional mini-BTE slim-tube open-fit hearing aids used in this trial. It should be noted, however, that we have failed previously to observe significant differences in hearing aid outcomes, for outcome measures similar to those in this study, for a wide range of hearing-aid technologies, including some that today would be representative of simpler OTC devices . More reOne could argue that the AB model evaluated here, including real-ear verification of targets, individual adjustment of maximum power output, and a hearing-aid orientation and counseling session, may still not be representative of “audiology best practices.” True best practices would also include follow-up appointments during the 6-week trial to adjust the devices in response to patient complaints. Guidelines for best practices in delivering hearing aids to adults from the American Academy of Audiology  and the On the other hand, one could argue that the CD participants experienced some aspects of audiology best practices, including a full audiological evaluation and medical clearance or waiver of such, and that this may have optimized the outcomes for the CD group. At the time this trial was initiated, the FDA required medical clearance (or waiver of such) for all hearing aids provided to consumers and, given what we knew at study inception, we considered it unethical to provide hearing aids to participants without a full audiological evaluation. It also could be argued that the restriction of the choice of devices to only three responses already pre-programmed for commonly encountered hearing losses to match NAL-NL2 targets, on average, and using the same hearing aids as those in the other two branches, unnecessarily constrained the range to be encountered in true OTC approaches. Again, it is acknowledged that the CD instantiation of the OTC approach here is just one of many possibilities, and it is up to others to validate alternative OTC approaches. However, the CD model does not seem to be too farfetched as an early approach to the delivery of OTC devices. Given the positive outcomes observed for the CD approach in this study, as well as the FDA's recent elimination of the medical-clearance requirement for hearing aids and its exploration of OTC devices as an alternative to hearing aids, the CD approach could certainly serve as a starting point against which other OTC service-delivery options could be compared.Finally, with regard to improvements in outcomes for the CD and P participants re-examined after an additional 4-week AB-based trial, it should be kept in mind that there could very well be an order bias such that scores the second time around may be higher due to additional experience with the hearing aids. We did not have participants assigned initially to the AB group complete a 4-week CD or P trial to counterbalance the order of service-delivery approaches. Our purpose for including the additional 4-week trial was based on the ethical treatment of participants and our state of the knowledge base at the inception of the clinical trial. Based on the knowledge available at the start of this clinical trial, the AB approach was considered superior and, due to random assignment to CD or P groups, those participants should not be deprived of a presumably superior service-delivery approach. AB participants could opt for an additional 4 weeks to evaluate adjustments to their devices, but they did not receive an alternative service-delivery model. On the other hand, arguing against a significant order effect or experience-based explanation of outcome improvements from Session 3 to Session 3B is the systematic nature of the improvements across outcome measures. For example, neither group showed improvement in PHABavds or usage. The no-gain P group showed significant improvements in PHABglobal, CST benefit, and HHIE benefit once adequate gain was provided. The CD group also showed significant improvement in PHABglobal, despite having a reasonable amount of gain in both Session 3 and Session 3B, but this could be due to better use of communication strategies discussed in the hearing-aid orientation. Finally, as indicated by the arrows showing the means from the original AB participants in This single-site double-blind placebo-controlled randomized clinical trial is the first to demonstrate that hearing aids are efficacious in older adults for an audiology-based best-practices (AB) service-delivery model. The efficacy of an alternative OTC approach (CD) in which the consumer selected pre-programmed devices was also established. Overall, the CD model of OTC service delivery yielded only slightly poorer outcomes than the AB model. Nonetheless, outcomes for CD participants (as well as P participants) improved significantly following a 4-week AB-based follow-up trial. Purchase price, $600 versus $3,600 per pair of hearing aids, had no effect on outcomes, but a high percentage (85%) of those who rejected hearing aids paid the higher of the two prices for their devices. Efficacious OTC service-delivery models (and devices) may increase accessibility and affordability of hearing aids for millions of older adults, but further research is required to evaluate various devices and approaches, as well as to examine the generalization of the findings from this clinical trial.10.1044/2017_AJA-16-0111SMS1Supplemental Material S1.Click here for additional data file.10.1044/2017_AJA-16-0111SMS2Supplemental Material S2.Click here for additional data file.10.1044/2017_AJA-16-0111SMS3Supplemental Material S3.Click here for additional data file.


The physical housing environment is important to facilitate activities of daily living (ADL) for older people. A hindering environment may lead to ADL dependence and thus increase the need for home services, which is individually restricting and a growing societal burden. This study presents simulations of policy changes with regard to housing accessibility that estimates the potential impact specifically on instrumental activities of daily living (I-ADL), usage of home services, and related costs. The models integrate empirical data to test the hypothesis that a policy providing funding to remove the five most severe environmental barriers in the homes of older people who are at risk of developing dependence in I-ADL, can maintain independence and reduce the need for home services. In addition to official statistics from state agencies in Sweden and Germany, we utilized published results from the ENABLE-AGE and other scientific studies to generate the simulations. The simulations predicted that new policies that remove potentially hindering housing features would improve I-ADL performance among older people and reduce the need for home services. Our findings suggest that a policy change can contribute to positive effects with regard to I-ADL independence among older people and to a reduction of societal burden. The acceleration of demographic ageing is one of the main challenges for European policy-making. As the baby-boom generation retires, the EU’s employed population will keep shrinking while the number of people aged over 60 will increase by about two million every year . The comFilling the gap for long-term care demand is today one of the main priorities of the European Union. The policy responses identified to tackle this challenge are raising the efficiency and effectiveness of care delivery; reducing the incidence and prevalence of frailty and disability; and enabling older people to continue to manage independent living with functional limitations .In this regard, the physical housing environment represents a key factor to facilitate activities of daily living (ADL) for older people ,3. A hinThus, from an environmental gerontology perspective, providing HA/HM serves to support the desire of the vast majority of community-dwelling older adults to independently age in place as long as possible and thus to retain their living environments which have become meaningful over decades of housing ,10,11. PWhen HA/HM are recognized as public services, the state and the municipalities are responsible for funding these interventions through taxation. In other national contexts, citizens can choose to buy their HA/HM on the market, with tax deductions systems (when available) partially covering the expenses . Sweden In Germany, HA/HM is provided by the private sector and can be refunded up to a maximum amount per measure and year (currently up to €4000) from the German care insurance system . PreciseWhile basic preconditions for housing in later life with regard to cultural, financial, and social conditions differ substantially between—for example—Northern and Southern Europe and between Western and Eastern Europe, Germany and Sweden are relatively similar in this regard. A comparison between these countries with regard to housing policies therefore appear meaningful.Data are generally difficult to find in countries where a public policy is lacking on HA/HM. On the contrary, in countries like Sweden data are available but the provision of HA as a legal right for all citizen makes it difficult to obtain estimates of the effectiveness of the intervention. Everyone in need in fact receives the grant and it is not feasible to identify a “control” group of older people not receiving the intervention . LikewisIn order to address the issue of accessible housing for older people, this study will present mathematical simulations of policy changes with regard to housing accessibility that estimate the potential impact specifically on the instrumental activities of daily living (I-ADL), usage of home services, and related costs. The policy to be simulated is to provide funding to remove the five most severe environmental barriers in the homes of older people who are at risk of developing dependence in I-ADL. The models integrate empirical data from different settings with the aim of testing the hypothesis that the new policy removing potentially hindering housing features can maintain independence in I-ADL among older people, thus reducing the overall need for home services.A key assumption of our model is that the degree of accessibility depends on the relation between barriers in the environment and the functional capacity of the individual see . ParticuIn line with this theoretical model, we thus hypothesize that the degree of housing accessibility impacts on the ability to perform ADL activities independently, so that those with housing that is more inaccessible are at greater risk to become dependent in ADL, and that this in turn also affects the need of home services ,22. DepeWe used data from the German and Swedish samples of the EU-funded ENABLE-AGE survey study , which cData on environmental barriers , functional limitations , and dependence on mobility devices was collected with the Housing Enabler instrument . A case-ADL dependence was assessed using the ADL Staircase , which ithe most prominent barriers in the two national housing stocks;the association of accessibility problem score and I-ADL dependence;the overall reduction of accessibility problems following the barrier’s removal;the cost of the barrier removal policy;the potential savings (in terms of home care provision cost) related to the policy impact.To model the impact of a hypothetical policy for barrier removal in Sweden and Germany, we estimated the following parameters in a step-by-step procedure:the barriers should be located indoors or at entrances;the barriers should have high impact on the range of potential accessibility problems generated, i.e., generating problems in relation to several functional capacities, such as vision, movement, handling and gripping etc., as shown by Slaug and colleagues ;the impact should also be potentially high in terms of severity, i.e., barriers more difficult to overcome, scoring at least 3 on the 1–4 scale;the barriers should be prevalent in ordinary housing, i.e., occurring in at least 33% of the surveyed dwellings.Assuming that it is not realistic to remove all possible barriers in the housing environment, we applied a procedure to select five prioritized barriers that would lead to the largest improvement in housing accessibility if removed for the entire at-risk population. Guiding criteria for this selection were:The barriers meeting all four criteria were ranked and the five that had the largest impact on the total accessibility problem score were selected.p < 0.05. All analyses were performed using STATA  [To estimate the impact of accessibility problems on I-ADL dependence, we utilized the baseline and one-year follow-up data from the ENABLE-AGE study. We first analyzed the independent effect of baseline accessibility problems (measured using the accessibility problem score) on the I-ADL at one-year follow-up by means of logistic regression models, adjusting for age, sex, and I-ADL dependence at baseline. That is, we used baseline housing accessibility problems to determine the increased risk of being dependent in each I-ADL after one year. The analysis was done for the German and Swedish samples separately. The level of significance was defined as TX, USA) .To analyze the impact of barrier removal—and the reduced accessibility problem score thus achieved—on I-ADL dependence we compared the outcome in terms of number of persons being dependent in I-ADL for two different scenarios, the real data scenario and a simulated scenario based on the removal of the five prioritized barriers identified in Step 1. We used the odds ratios for the impact of the accessibility problem score on I-ADL dependence retrieved from the Step 2 logistic regression analyses (effect of a 1-point reduction in accessibility problem score) in order to calculate how many persons would have been dependent after one year in such a simulated scenario. We then calculated the “number needed to treat”  in orderWe identified—as the ideal target population for our suggested barrier removal policy—older people living independently in the community with some difficulties, but not yet receiving any support service from the formal sector. In order to estimate the size of this population segment, we used the most recent figures available from official registers in Sweden  and GermWe first selected the same age ranges of population included in the ENABLE-AGE samples (80 to 90 years) and subtracted the estimated proportion of people living in assisted living. Thereafter, we estimated how many people were still independent but with some difficulty in I-ADL, as we assumed these to be those at highest risk of falling into dependence. These prevalences were estimated from ENABLE-AGE data. Finally, to define the target population size for our policy of barrier removal, we subtracted the proportion of those already receiving home services according to official statistics ,31. To eTo estimate the savings in terms of total costs for home services, we utilized data on the average number of hours per week that people receive home services in both countries. For Germany, we retrieved this data from the Medical Advisory Service of the German Associating of Statutory Health Insurance Funds , and froAll subjects gave their informed consent for inclusion before they participated in the ENABLE-AGE survey study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of Lund University .Twenty-six barriers fulfilled the four selection criteria in the Swedish sample, 21 in the German sample. From these barriers, we selected the five barriers in each national sample that would impact the housing accessibility (in terms of accessibility problem score reduction) most. The five barriers thus prioritized for removal are presented in The effect of a one-point change in housing accessibility on each of the I-ADL is shown in Assuming a 14- and 16-point reduction in housing accessibility in the German and Swedish samples, respectively, and the odds ratios in The size of the intervention target populations for the new barrier removal policy were 477,592 homes in Germany 51,536 homes in Sweden. For further details, see The potential reduction in costs for home services, when applying the results of the simulation analysis at the population level, is shown in This study simulated the impact of policy changes in the area of housing accessibility, in terms of I-ADL dependency level, usage of home services and related costs. Our calculations integrated empirical data from the EU-funded ENABLE-AGE project in Sweden and Germany with publicly available statistics, testing the hypothesis that new policies to reduce potentially hindering housing features can help to maintain independence in I-ADL performance among older people who age in place. The main result of the simulation was that substantial numbers of cases of I-ADL dependence could be averted, thus reducing societal costs for home services.However, an open question remains as to whether or not the reduction of costs can make up for the cost of barrier removals. Even if the costs for the new policy of barrier removals are large, it should be kept in mind that these are one-time costs, while costs for home services are likely to be repeated over time and potentially increase with deteriorating health. In our model, after a little more than one year in Sweden, and after two and half years in Germany, the initial cost for the new policy would have paid off, and after that date, an annual gain is likely to occur. Such gains can be higher the longer we enable persons to remain independent in I-ADL activities.Our simulations show that improved accessibility of the ordinary housing stock has the potential to maintain or improve the health of our ageing population. Today, similar tools for preparing and making informed policy decisions are still largely lacking, whereas policy makers need such support to take decisions that are accurate and efficient. By developing simulation models based on the best knowledge available, this study provides policy makers with preliminary long-term predictions of the impact of housing adaptation policies.There are, however, significant study limitations that have to be considered. The effect of barrier removal on accessibility problems is based on ENABLE-AGE data, but also on theoretical assumptions with respect to this relationship. While the ENABLE-AGE samples were randomly selected they were only recruited regionally around the study sites in each country. We therefore, cannot be certain that they are truly representative of the national population of single living people aged 80–90 years of either country. While it was not possible to weight the ENABLE-AGE data to simulate a national sample due to the sampling frame, we did use national statistics to estimate the proportions of people living independently who would be recipients of the policy intervention. The one-year follow-up period causes additional limitations. The association between housing accessibility and I-ADL may be biased toward a healthier sample as those who were sicker were less likely to complete the follow-up. However, we expect that if the sicker participants had been able to complete the follow-up, it would have actually led to a larger effect, and therefore, we believe our estimates are likely more conservative. Moreover, keeping in mind that we only have a one year follow-up, we do not know for how long the positive effects will be stable beyond this time frame. That is, for how long can I-ADL dependence be delayed?The ageing population in combination with the deficiencies in the ordinary housing stock thus calls for large-scale measures . HoweverAn ordinary housing stock that can accommodate an ageing population is of utmost importance from a public health perspective. The present simulations did not take into account the potential reductions in costs related to maintenance of health or informal care. A housing environment that is not accessible also increases the risk for a lower degree of social participation, which can turn into poorer self-management, isolation, and ultimately higher health care needs . FurtherKeeping the study limitations in mind, our findings suggest that a policy that provides funding to remove the most severe environmental barriers in the homes of older people who are at risk of developing dependence in I-ADL, can contribute to positive effects in terms of maintaining I-ADL independence among community-dwelling older people. Moreover, considering a time perspective, our findings suggest such a policy change can achieve a reduction of societal burden in terms of provision of home services. Such models can provide policy makers with the tools needed to make informed decisions when weighing future policy options to enhance quality of life while minimizing costs.