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"Hearing aids."
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Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing
2025
Only 15% of the nearly 30 million Americans with hearing loss use hearing aids, partly due to high cost, stigma, and limited access to professional hearing care. Hearing impairment in adults can lead to social isolation and depression and is associated with an increased risk of falls. Given the persistent barriers to hearing aid use, the Food and Drug Administration issued a final rule to allow over-the-counter hearing aids to be sold directly to adult consumers with perceived mild to moderate hearing loss at pharmacies, stores, and online retailers without seeing a physician or licensed hearing health care professional.
We evaluated the safety and usability of an over-the-counter hearing aid prior to Food and Drug Administration approval and market release.
We first conducted a formative usability test of the device and associated app with 5 intended users to identify outstanding safety and usability issues (testing round 1). Following design modifications, we performed a summative usability test with 15 intended users of the device (testing round 2). We concurrently conducted a test with 21 nonintended users (ie, users with contraindications to use) to ascertain if consumers could determine when they should not use the device, based on the packaging, instructions, and labeling (testing round 3). Participants were asked to complete 2-5 tasks, as if they were using the hearing aid in real life. After each task, participants rated the task difficulty. At the end of each session, participants completed a 10-question knowledge assessment and the System Usability Scale and then participated in debriefing interviews to gather qualitative feedback. All sessions were video recorded and analyzed to identify use errors and design improvement opportunities.
Usability issues were identified in all 3 usability testing rounds. There were minimal safety-related issues with the device. Round 1 testing led to several design modifications which then increased task success in round 2 testing. Participants had the most difficulty with the task of pairing the hearing aids to the cell phone. Participants also had difficulty distinguishing the right and left earbuds. Nonintended users did not always understand device contraindications (eg, tinnitus and severe hearing loss). Overall, test findings informed 9 actionable design modifications (eg, clarifying pairing steps and increasing font size) that improved device usability and safety.
This study evaluated the usability and safety of an over-the-counter hearing aid for adults with mild to moderate hearing loss. Human factors engineering methods identified opportunities to improve the safety and usability of this direct-to-consumer medical device for individuals with perceived mild-moderate hearing loss.
Journal Article
Validation of a Self-Fitting Method for Over-the-Counter Hearing Aids
by
Sabin, Andrew T.
,
Van Tasell, Dianne J.
,
Rabinowitz, Bill
in
Audiology
,
Best practice
,
Hearing aids
2020
In common practice, hearing aids are fitted by a clinician who measures an audiogram and uses it to generate prescriptive gain and output targets. This report describes an alternative method where users select their own signal processing parameters using an interface consisting of two wheels that optimally map to simultaneous control of gain and compression in each frequency band. The real-world performance of this approach was evaluated via a take-home field trial. Participants with hearing loss were fitted using clinical best practices (audiogram, fit to target, real-ear verification, and subsequent fine tuning). Then, in their everyday lives over the course of a month, participants either selected their own parameters using this new interface (Self group; n = 38) or used the parameters selected by the clinician with limited control (Audiologist Best Practices Group; n = 37). On average, the gain selected by the Self group was within 1.8 dB overall and 5.6 dB per band of that selected by the audiologist. Participants in the Self group reported better sound quality than did those in the Audiologist Best Practices group. In blind sound quality comparisons conducted in the field, participants in the Self group slightly preferred the parameters they selected over those selected by the clinician. Finally, there were no differences between groups in terms of standard clinical measures of hearing aid benefit or speech perception in noise. Overall, the results indicate that it is possible for users to select effective amplification parameters by themselves using a simple interface that maps to key hearing aid signal processing parameters.
Journal Article
A Review of Machine Learning Approaches for the Personalization of Amplification in Hearing Aids
by
Ni, Aoxin
,
Tasnim, Nafisa Zarrin
,
Lobarinas, Edward
in
Customization
,
Hearing aids
,
Hearing loss
2024
This paper provides a review of various machine learning approaches that have appeared in the literature aimed at individualizing or personalizing the amplification settings of hearing aids. After stating the limitations associated with the current one-size-fits-all settings of hearing aid prescriptions, a spectrum of studies in engineering and hearing science are discussed. These studies involve making adjustments to prescriptive values in order to enable preferred and individualized settings for a hearing aid user in an audio environment of interest to that user. This review gathers, in one place, a comprehensive collection of works that have been conducted thus far with respect to achieving the personalization or individualization of the amplification function of hearing aids. Furthermore, it underscores the impact that machine learning can have on enabling an improved and personalized hearing experience for hearing aid users. This paper concludes by stating the challenges and future research directions in this area.
Journal Article
Bone-anchored hearing system, contralateral routing of signals hearing aid or cochlear implant: what is best in single-sided deafness?
by
Aschendorff, Antje
,
Speck, Iva
,
Ketterer, Manuel C.
in
Cochlear Implantation
,
Cochlear Implants
,
Deafness - surgery
2022
Purpose
The aim of the study was to compare long-term results after 1 year in patients with single-sided deafness (SSD) who were fitted with different hearing aids. The participants tested contralateral routing of signals (CROS) hearing aids and bone-anchored hearing systems (BAHS). They were also informed about the possibility of a cochlear implant (CI) and chose one of the three devices. We also investigated which factors influenced the choice of device.
Methods
Prospective study with 89 SSD participants who were divided into three groups by choosing BAHS, CROS, or CI. All participants received test batteries with both objective hearing tests (speech perception in noise and sound localisation) and subjective questionnaires.
Results
16 participants opted for BAHS-, 13 for CROS- and 30 for CI-treatment. The greater the subjective impairment caused by SSD, the more likely patients were to opt for surgical treatment (BAHS or CI). The best results in terms of speech perception in noise (especially when sound reaches the deaf ear and noise the hearing ear), sound localization, and subjective results were achieved with CI.
Conclusion
The best results regarding the therapy of SSD are achieved with a CI, followed by BAHS. This was evident both in objective tests and in the subjective questionnaires. Nevertheless, an individual decision is required in each case as to which SSD therapy option is best for the patient. Above all, the patient's subjective impairment and expectations should be included in the decision-making process.
Journal Article
Factors Influencing Hearing Help-Seeking and Hearing Aid Uptake in Adults: A Systematic Review of the Past Decade
2023
This systematic review examined the audiological and nonaudiological factors that influence hearing help-seeking and hearing aid uptake in adults with hearing loss based on the literature published during the last decade. Peer-reviewed articles published between January 2011 and February 2022 were identified through systematic searches in electronic databases CINAHL, PsycINFO, and MEDLINE. The review was conducted and reported according to the PRISMA protocol. Forty-two articles met the inclusion criteria. Seventy (42 audiological and 28 nonaudiological) hearing help-seeking factors and 159 (93 audiological and 66 nonaudiological) hearing aid uptake factors were investigated with many factors reported only once (10/70 and 62/159, respectively). Hearing aid uptake had some strong predictors (e.g., hearing sensitivity) with others showing conflicting results (e.g., self-reported health). Hearing help-seeking had clear nonpredictive factors (e.g., education) and conflicting factors (e.g., self-reported health). New factors included cognitive anxiety associated with increased help-seeking and hearing aid uptake and urban residency and access to financial support with hearing aid uptake. Most studies were rated as having a low level of evidence (67%) and fair quality (86%). Effective promotion of hearing help-seeking requires more research evidence. Investigating factors with conflicting results and limited evidence is important to clarify what factors support help-seeking and hearing aid uptake in adults with hearing loss. These findings can inform future research and hearing health promotion and rehabilitation practices.
Journal Article
Validation of a Self-Fitting Over-the-Counter Hearing Aid Intervention Compared with a Clinician-Fitted Hearing Aid Intervention: A Within-Subjects Crossover Design Using the Same Device
by
Kokkinakis, Kosta
,
Nelson, Peggy B.
,
Yellamsetty, Anusha
in
Adult
,
Aged
,
Correction of Hearing Impairment - instrumentation
2025
In October of 2022, the US Food and Drug Administration finalized regulations establishing the category of self-fitting over-the-counter (OTC) hearing aids, intended to reduce barriers to hearing aid adoption for individuals with self-perceived mild to moderate hearing loss. Since then a number of self-fitting OTC hearing aids have entered the market, and a small number of published studies have demonstrated the effectiveness of a self-fitted OTC intervention against a traditional clinician-fitted intervention. Given the variety of self-fitting approaches available, and the small number of studies demonstrating effectiveness, the goal of the present study was to evaluate the effectiveness of a commercially available self-fitting OTC hearing aid intervention against a clinician-fitted intervention. Consistent with previous studies, we found that the self-fitted intervention was not inferior to the clinician-fitted intervention for self-reported benefit and objective speech-in-noise outcomes. We found statistically significant improvements in self-fitted outcomes compared to clinician-fitted outcomes, though deviations from best audiological practices in our clinician-fitted intervention may have influenced our results. In addition to presenting our results, we discuss the state of evaluating the noninferiority of self-fitted interventions and offer some new perspectives.
Journal Article
Access to adults’ hearing aids: policies and technologies used in eight countries
by
Reed, Nicholas S
,
Lin, Frank R
,
Willink, Amber
in
Access
,
Acquired immune deficiency syndrome
,
Adaptation
2019
As the proportion of older adults in the world's total population continues to grow, the adverse health outcomes of age-related hearing loss are becoming increasingly recognized. While research has shown that age-related hearing loss is the single greatest modifiable risk factor for dementia, use of hearing aids remains low worldwide, even in many middle- and high-income countries. Reasons for poor uptake of hearing aids are likely to involve a combination of factors, ranging from increasing costs of hearing aid technology to a widespread lack of insurance coverage. This article aims to identify the current state of access to hearing aids, focusing on eight middle- and high-income countries. We discuss how to facilitate greater access to hearing aids for patients by addressing changes in how devices are regulated, technological advancements in hearing devices, the need to adjust reimbursement schemes and the importance of adaptation among the community workforce for hearing-care.
Journal Article
Effectiveness of a Web-Based SUpport PRogram (SUPR) for Hearing Aid Users Aged 50+: Two-Arm, Cluster Randomized Controlled Trial
by
Meijerink, Janine FJ
,
Lissenberg-Witte, Birgit I
,
Pronk, Marieke
in
Aged
,
Female
,
Hearing Aids - statistics & numerical data
2020
Hearing aid (HA) use is known to improve health outcomes for people with hearing loss. Despite that, HA use is suboptimal, and communication issues and hearing-related activity limitations and participation restrictions often remain. Web-based self-management communication programs may support people with hearing loss to effectively self-manage the impact of hearing loss in their daily lives.
The goal of the research is to examine the short- and long-term effects of a web-based self-management SUpport PRogram (SUPR) on communication strategy use (primary outcome) and a range of secondary outcomes for HA users aged 50 years and older.
Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users). SUPR recipients received a practical support booklet and online materials delivered via email over the course of their 6-month HA rehabilitation trajectory. They were encouraged to appoint a communication partner and were offered optional email contact with the HA dispensing practice. The online materials included 3 instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos. Care as usual included a HA fitting rehabilitation trajectory only. Measurements were carried out at baseline, immediately postintervention, 6 months postintervention, and 12 months postintervention. The primary outcome measure was self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI]). Secondary outcome measures included self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids [IOI-HA], Alternative Interventions [IOI-AI]); recommendation of HA dispensing services; self-efficacy for HA handling (Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [MARS-HA]); readiness to act on hearing loss (University of Rhode Island Change Assessment adapted for hearing loss [URICA-HL]); and hearing disability (Amsterdam Inventory for Auditory Disability and Handicap [AIADH]).
Linear mixed model analyses (intention to treat) showed no significant differences between the SUPR and control group in the course of communication strategy use (CPHI). Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04). Also, SUPR recipients showed significantly greater HA satisfaction than controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.09 to 0.5; P=.006), which was sustained at 12 months, and significantly greater HA use than the controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.02 to 0.5; P=.03), which was not sustained at 12 months.
This study provides ground to recommend adding SUPR to standard HA dispensing care, as long-term, modest improvements in HA outcomes were observed. Further research is needed to evaluate what adjustments to SUPR are needed to establish long-term effectiveness on outcomes in the psychosocial domain.
ISRCTN77340339; http://www.isrctn.com/ISRCTN77340339.
RR2-10.1136/bmjopen-2016-015012.
Journal Article