Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption, even in high-income countries with developed audiological services . Traditionally, hearing aids required professional consultations, restricting access. However, in 2022, the U.S. FDA approved over-the-counter (OTC) hearing aids, including self-fitting devices, to improve accessibility. Recent clinical trials suggest that OTC hearing aids can deliver similar benefits to professionally fitted ones in speech recognition and self-reported outcomes. Critiques of these studies have focused on using the same device model for both groups rather than comparing it to established prescription hearing aids. To address this, the current study employs a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer, Phase 2 assesses user experience, and Phase 3 involves a randomized control trial comparing a self-fitting OTC hearing aid with a professionally fitted prescription device. The hypothesis is that both devices offer equivalent benefits. This research is novel as no previous studies have directly compared self-fitting OTC and commercially available prescription hearing aids. This study will compare the effectiveness of an OTC self-fitting hearing aid against a prescription device using a crossover randomized control trial.
Hearing loss is a prevalent condition affecting a significant portion of the global population, leading to challenges in communication, social interactions, and overall quality of life. Recent data indicates that over 1.5 billion individuals worldwide experience some degree of hearing loss, with 430 million facing disabling hearing impairments. For adults with sensorineural hearing loss, hearing aids are the primary intervention to enhance auditory function. Conventionally, obtaining hearing aids involves comprehensive diagnostic assessments, device selection, and personalized fitting conducted by hearing care professionals. While this method ensures tailored care, it can also pose accessibility challenges, including financial constraints, limited availability of trained professionals, and social stigma associated with hearing aid use. These barriers contribute to the limited adoption and underutilization of hearing aids, even in regions with adequate audiological services. To address these accessibility issues, over-the-counter (OTC) hearing aids have been introduced as a viable alternative. This model empowers individuals with perceived mild to moderate hearing loss to independently select and fit hearing aids without the necessity of professional evaluations. The U.S. Food and Drug Administration (FDA) established regulations for OTC hearing aids, which took effect on October 17, 2022. These regulations aim to increase accessibility and affordability of hearing care solutions. The introduction of OTC hearing aids represents a shift towards consumer hearing care. By allowing individuals to manage their hearing needs independently, OTC hearing aids have the potential to reduce barriers associated with traditional hearing aid procurement, such as high costs and limited access to audiologists. This newer model of care aligns with a broader public health goal to enhance the availability of hearing aids. Recent clinical trials have indicated that over-the-counter (OTC) hearing aids can provide benefits comparable to those of professionally fitted devices, particularly in the areas of user-reported satisfaction. For instance, a randomized clinical trial compared the effectiveness of a self-fitting OTC hearing aid with remote support to that of an audiologist-fitted device. The study found that self-reported outcomes and speech recognition in noise benefits were noninferior in the self-fitting group compared to the audiologist-fitted group. Despite these promising findings, critiques have emerged regarding the methodologies of this and other similar studies. A primary concern is that many studies utilize the same device model for both the OTC and professionally fitted groups, rather than comparing OTC devices to established prescription hearing aids. This approach may limit the generalizability of the results, as it does not account for the variability in performance across different hearing aid models. Therefore, there is a need for studies that compare self-fitting OTC hearing aids directly with prescription devices to provide a more comprehensive understanding of their relative effectiveness. The aim of this randomized controlled trial is to compare the effectiveness of a self-fitting OTC hearing aid to a prescription hearing aid. This trial forms a part of a larger validation study, that includes two other phases (validating an in-situ hearing test and usability assessment of the self-fitting OTC hearing aid). However, we describe here only the effectiveness trial (Phase 3). The hypothesis is that the self-fitting OTC hearing aid will provide non-inferior benefits compared to the professionally fitted prescription hearing aid in terms of user-reported outcomes and speech recognition in noise. Several other exploratory measures will also be evaluated through the course of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
OTC hearing aid to be compared to prescription hearing aid
Prescription hearing aid used as active comparator to the OTC self-fitting hearing aid
Abbreviated Profile of Hearing Aid Benefit (APHAB)
The APHAB will be the primary effectiveness endpoint measure for the trial. It is a standardised questionnaire used to assess the effectiveness of hearing aids. It measures the user's perceived hearing difficulties in various everyday situations both with and without their hearing aids, across four subscales: ease of communication, reverberation, background noise, and aversiveness of sounds. The results help to quantify the benefits and limitations of hearing aid use from the user's perspective. The APHAB global score is calculated by averaging the scores across three specific subscales of the APHAB: Ease of Communication, Reverberation, and Background Noise and will serve as the primary effectiveness outcome variable for the study phase. Patients report the percentage of time they experience difficulty in each situation (1% - 99%), with and without hearing aids. Benefit is calculated by comparing the unaided and aided scores, with higher benefit scores indicating better outcomes.
Time frame: Baseline, three weeks and six weeks
International Outcome Inventory for Hearing Aids (IOI-HA)
The IOI-HA is a standardised questionnaire designed to evaluate the overall effectiveness and user satisfaction with hearing aids. It consists of seven items that assess key aspects such as daily use, benefit, residual activity limitations, satisfaction, residual participation restrictions, impact on others, and quality of life. The scale is ordinal in nature, but a total score can be calculated as the sum of all seven items. Each item is rated on a 5-point scale, with higher scores indicating more favorable outcomes. The total score ranges from 7 to 35, with higher scores reflecting greater benefit and satisfaction from hearing aid use.
Time frame: Three weeks and six weeks
Quick Speech in Noise Test (QuickSIN)
The QuickSIN is a clinically used assessment tool designed to evaluate an individual's ability to understand speech in noisy environments by presenting speech in multi-talker babble noise. During the test, six sentences-each containing five key words-are presented with four-talker babble noise. The speech level decreases in 5 dB steps from a signal-to-noise ratio (SNR) of 25 dB to 0 dB. Patients repeat each sentence, and clinicians score one point for each correctly repeated key word, totaling up to 30 points per list. The SNR loss is calculated by subtracting the total correct words from 25.5. Lower SNR loss values indicate better speech understanding in noisy environments. Three lists will be completed at each assessment point, and the average SNR of the three lists will be used for the final calculation.
Time frame: Baseline, three weeks and six weeks
Real ear aided response (REAR)
REAR is a measure used to evaluate the sound level at the eardrum when a hearing aid is worn and active. It captures how the hearing aid amplifies sound across different frequencies directly in the user's ear canal. In relation to NAL-NL2 targets, REAR is used to verify that the hearing aid's amplification matches the prescribed targets set by the NAL-NL2 fitting formula. NAL-NL2 is a widely used prescriptive method for fitting hearing aids, aiming to optimise speech intelligibility while maintaining comfort. During a fitting, the audiologist measures the REAR and compares it to the NAL-NL2 targets to ensure that the hearing aid is providing the appropriate gain for the user's specific hearing loss, ensuring optimal hearing aid performance and user satisfaction. We will determine how far the REAR is from NAL-NL2 prescriptive target in decibel sound pressure level \[dB SPL\] at 0.5, 1,2 and 4 kHz. A lower number in dB SPL (NAL-NL2 target - REAR) suggests closer alignment to target.
Time frame: Three weeks and six weeks
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