WithdrawnNot Applicable

Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid

Stopped: The study was withdrawn before enrollment for administrative reasons.

0Started 2025-09-01

Plain-language summary

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.

Who can participate

Age range18 Years – 110 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. …

What they're measuring

Abbreviated Profile of Hearing Aid Benefit (APHAB)

Timeframe: Baseline, three weeks and six weeks

Trial details

NCT IDNCT06942325

SponsorHearX SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31