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

NCT06942325 | Withdrawn DMC

• 1 other identifier: Lexie
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hearing Loss; Hearing Impairment

Keywords

hearing loss; over-the-counter hearing aid; self-fitting hearing aid; prescription hearing aid

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, three weeks and six weeks

Secondary Outcomes (3)

• International Outcome Inventory for Hearing Aids (IOI-HA)

  Three weeks and six weeks

• Quick Speech in Noise Test (QuickSIN)

  Baseline, three weeks and six weeks

• Real ear aided response (REAR)

  Three weeks and six weeks

Other Outcomes (8)

• Revised Hearing Handicap Inventory - Screening (RHHI-S)

  Baseline, three weeks and six weeks

• Hearing aid skills and knowledge inventory-clinician (HASKI-Clin)

  Three weeks and six weeks

• Generalized Self Efficacy Scale (GSES)

  Baseline

Study Arms (2)

OTC SF Group

EXPERIMENTAL

Participants in this group will field trial a self-fitting over-the-counter (OTC SF) hearing aid. Each participant will independently set up and adjust their device without any professional assistance, following standard self-fitting procedures. They will receive only the manufacturer-provided instructional materials, including the user manual and quick start guide, as would be typical for real-world OTC hearing aid use. This process reflects the intended consumer-directed experience for OTC hearing aids.

Device: OTC self-fitting hearing aid

Prescription Group

ACTIVE COMPARATOR

Participants in this group will use a professionally fitted prescription hearing aid. A licensed audiologist will conduct a comprehensive hearing evaluation, followed by device selection (receiver wires and domes), programming, and individualized fitting based on best practice protocols. The fitting will be fine-tuned using real-ear measurements (REM) to ensure optimal amplification settings tailored to each participant's hearing profile. Additionally, participants will receive professional counseling on device use, care, and expectations, reflecting the standard clinical hearing aid fitting process.

Device: Prescription hearing aid

Interventions

OTC self-fitting hearing aid DEVICE

OTC hearing aid to be compared to prescription hearing aid

Also known as: OTC hearing aid

OTC SF Group

Prescription hearing aid DEVICE

Prescription hearing aid used as active comparator to the OTC self-fitting hearing aid

Prescription Group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HearX SA: lead

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karina C De Sousa, PhD

  hearX Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 24, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share