MedTrace Logo

Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid

NCT06878300 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-11-20

No results posted yet for this study

Summary

Hearing loss significantly impacts quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a well-established intervention, yet barriers such as access and affordability limit their adoption, even in countries with developed audiological services . Despite their proven benefits, many individuals who could benefit from hearing aids do not obtain them. Traditionally, hearing aids required professional consultations, which created access challenges. 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 provide similar benefits to professionally fitted ones in speech recognition and self-reported outcomes.

One critique of past studies is that they often compare OTC hearing aids to audiologist-fitted devices using the same hardware, with differences primarily in programming methods. While much research has focused on fitting methods, this study aims to evaluate a new OTC hearing aid with its proprietary fitting algorithm against a marketed competitor. This randomized controlled trial (RCT) forms part of a larger validation study that follows a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer and Phase 2 assesses user experience. This RCT (Phase 3) will compare two OTC devices-the Lexie B3 Pro and a competitor already on the market-to evaluate self-reported benefit, user experience, and satisfaction. The hypothesis is that both devices provide comparable outcomes.

Conditions

Interventions

DEVICE

Over the counter hearing aid (Lexie)

The study will compare user perceptions of two over-the-counter (OTC) hearing aids, with the Lexie B3 Pro serving as the reference device. Participants will be fitted with each device for a predetermined period in a randomized order to ensure balanced exposure.

DEVICE

Comparator over the counter hearing aid

The comparator OTC hearing aid will undergo the same evaluation process as the Lexie B3 Pro, ensuring an equivalent and unbiased comparison. Participants will be provided with the comparator device along with its standard user instructions, including any mobile applications or self-fitting guidance designed for independent setup.

Sponsors & Collaborators

  • HearX SA

    lead INDUSTRY

Principal Investigators

  • Karina C De Sousa, PhD · hearX Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-08-31
Completion
2025-08-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06878300 on ClinicalTrials.gov