The study was withdrawn before enrollment for administrative reasons.

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.

Inclusion criteria:

• Participant must be 18 years or older.
• The outer ear must be free from excessive cerumen, outer or middle ear disease (determined through otoscopic examination of the ear)
• The participant must have bilateral self-perceived mild-moderate hearing loss.
• Baseline pure tone evaluations should fall within a 4-frequency PTA (0.5, 1.0, 2.0, 4.0 kHz) of 65 dB HL or less.
• The participant must have an adequate level of English proficiency as measured objectively using an English proficiency test (EF SET).
• The participant must have Type A or As or Ad tympanogram as measured by tympanometry.
• Must be in possession of a smartphone compatible with the Lexie App (minimum iOS 13 or Android OS 10), preferably within equal distributio

Exclusion Criteria:

• Younger than 18 years
• Presents with severe or greater hearing loss in either ear
• Presents with an outer or middle ear abnormality

Have any of the following as per FDA (21 CFR 801.420) reg-flag conditions as contraindications to OTC hearing aid use :

(i) Visible congenital or traumatic deformity of the ear preventing insertion of the receiver wire and dome into the ear.

(ii) History of sudden active drainage (i.e. blood or pus) from the ear within the previous 6 months.

(iii) Painful or uncomfortable feeling in your ear (iv) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.

(v) History of sudden or rapidly progressive hearing loss within the previous 6 months.

(vi) Acute or chronic dizziness. (vii) Unilateral hearing loss. (viii) Fluctuating hearing loss (ix) Unilateral tinnitus

• Low English proficiency - <51% of EF-SET
• No access or in possession of a smartphone, compatible with the Lexie App (minimum iOS 13 or Android OS 10)

The study is conducted under the South African Health Products Regulatory Authority (SAHPRA) and US Food and Drug Administration (FDA) Institutional regulations, which impose strict guidelines on the handling and sharing of medical device trial data. Furthermore, the data may contain proprietary or commercially sensitive information related to the device's performance. Sharing IPD could compromise intellectual property or competitive interests of the device manufacturer. While the raw IPD will not be shared, aggregate-level data, summary statistics, and study findings may be published and made available in peer-reviewed journals and reports.