NCT05782153

Comparing Self-Fitting Strategies in the Lexie Powered by Bose Hearing Aids

Completed NA Last updated 29 February 2024

What this trial tests

NA trial testing Intervention A (hearing aid self-fitting with direct adjustment) in Hearing Loss in 40 participants. Completed in 14 November 2023.

Timeline

17 July 2023

Primary endpoint
14 November 2023

14 November 2023

Quick facts

Lead sponsor	hearX Group
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	17 July 2023
Primary completion	14 November 2023
Estimated completion	14 November 2023
Sites	1 location across South Africa

Drugs / interventions tested

• Intervention A (hearing aid self-fitting with direct adjustment)
• Intervention B (hearing aid self-fitting with in-situ fitting)

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

hearX Group

Who can join

18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

More than 1.5 billion people around the world experience hearing loss, of whom at least 430 million experience disabling hearing loss that will require rehabilitation. The majority of people have mild to moderate hearing loss and can benefit from hearing aids. However, hearing aid adoption around the world has been low, with global hearing aid coverage being less than 11%. This is partly due to limited access to hearing healthcare services and the high cost of hearing devices.

However, there have been significant efforts to improve access to hearing healthcare services. This includes rapid advances in hearing aids and new service-delivery models leading to more affordable and accessible options such as Over-the-Counter (OTC) hearing aids. On the 17th of October 2022, the Food and Drug Administration (FDA) established a regulatory category for OTC hearing aids. The final rule allows consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting by an audiologist. The FDA defined two sub-categories for OTC hearing aids, namely 1) OTC hearing aids with standardized output profiles (i.e., pre-set programs) and 2) self-fitting OTC hearing aids which allow users to program their hearing aids with a self-fitting strategy and also customize their hearing aid settings according to their needs and preferences.

Sabin et al. (2020) was the first study to validate a self-fitting method using the Bose prototype hearing aid. This self-fitting method allowed users to select their own signal processing parameters using a mobile application consisting of two wheels that simultaneously control the gain and compression of all frequency bands. Sabin et al. (2020) evaluated the real-world performance of this approach by comparing gain, sound quality and clinical measures of hearing aid benefit and satisfaction between a group using the self-fitting method and a group that was professionally fitted with the same hearing aid. The gain selected by the self-fit group was within 1.8 dB overall and 5.6 dB per band compared to the gain selected by the audiologist. Participants in the self-fit group reported better sound quality, and there were no differences in clinical measures of hearing aid benefit or satisfaction.

Although a number of studies have compared self-fitting OTC devices to conventional hearing aids fitted by hearing healthcare professionals, no study has compared different self-fitting strategies in the same OTC device. Therefore, this study aims to compare the existing self-fitting strategy of the Lexie Powered by Bose hearing aids (i.e., direct adjustment) to a recently validated in-situ audiometry fitting strategy. The in-situ audiometry fitting strategy consists of in-situ thresholds measurements conducted at 500, 1000, 2000 and 4000 Hz through the hearing aids, which will be used with a proprietary fitting algorithm that is based on National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2) to self-program the hearing aids.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial.
   Knoetze M, Manchaiah V, De Sousa K, Moore DR, et al · · 2024 · cited 8× · PMID 39052241 · DOI 10.1001/jamaoto.2024.2007