NCT05782153

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

Comparing Self-Fitting Strategies in the Lexie Powered by Bose Hearing Aids: A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: hearX Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

* Objective: To compare an in-situ audiometry self-fitting strategy to the Bose self-fitting strategy (i.e., direct adjustment) using the same Lexie B2 Powered by Bose hearing aids. Hearing aid benefit and satisfaction will be compared in the same participants between the two fitting strategies. Additionally, Real Ear Measurements (REM) and speech perception will be compared in the same participants between the two fitting strategies. * Hypothesis: The investigators hypothesize that there will be no statistically significant difference in terms of perceived hearing aid benefit and satisfaction, REM and speech perception within the same individual after receiving intervention A (hearing aid self-fitting with direct adjustment) and intervention B (hearing aid self-fitting with in-situ fitting) in a randomized, double-blind, cross-over within-subjects controlled trial. * Design: Randomized, double-blind, cross-over within-subject controlled trial comparing an in-situ audiometry self-fitting strategy to the Bose self-fitting strategy (i.e., direct adjustment) using the same Lexie B2 Powered by Bose hearing aids in the same participants, which allows for participants to be their own control (n=40). * Setting: This study will involve clinical audiometric testing at the Department of Speech-Language Pathology and Audiology, University of Pretoria, as well as a user field trial of the fitted hearing aids using each fitting strategy. * Participants: Eligible participants will include 40 adults (\>18 years) with a self-perceived mild-to-moderate level of hearing loss, without symptoms of outer- and middle ear pathology and who own a smartphone with access to mobile data (Android or iOS). Participants will be recruited and will randomly be assigned to a group using computer-generated randomization by an independent research assistant after being stratified for sex and degree of hearing loss. * Intervention: Forty participants will randomly be assigned to be fitted with intervention A (hearing aid self-fitting with direct adjustment) or intervention B (hearing aid self-fitting with in-situ fitting) and wear the hearing aids for four weeks. After four weeks, they will be crossed over to be fitted with the alternative fitting strategy, and they will wear the hearing aids again for four weeks. * Outcome measures: The primary outcome measure will be the Abbreviated Profile of Hearing Aid Benefit (APHAB). The secondary outcome measures will be the International Outcome Inventory for Hearing Aids (IOI-HA), Overall experience rating, REM, the QuickSIN speech-in-noise test and the Digits-in-noise test.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Intervention A (hearing aid self-fitting with direct adjustment)	The intervention offered is a hearing aid fitting with the Lexie B2 Powered by Bose receiver-in-the-canal hearing aids using a self-fitting strategy with direct adjustment. The hearing aids will be accompanied and operated with the Lexie smartphone application. Participants will complete a hearing screening (at 500, 1000, 2000 and 4000 Hz) called Hearing Check on the Lexie smartphone application, which will be used to tune the hearing aids according to frequency and loudness level. Participants will be able to use two wheels to change the loudness and fine-tune the hearing aids. Participants will wear the hearing aids for four weeks.
DEVICE	Intervention B (hearing aid self-fitting with in-situ fitting)	The intervention offered is a hearing aid fitting with the Lexie B2 Powered by Bose receiver-in-the-canal hearing aids using the in-situ audiometry fitting strategy. The hearing aids will be accompanied and operated with the Lexie smartphone application. Participants will complete an in-situ audiogram on the Lexie app, which enables the measurement of hearing thresholds through the hearing aids (at 500, 1000, 2000 and 4000 Hz). The hearing aids will then be self-programmed according to the participant's in-situ audiogram with a proprietary fitting algorithm that is based on NAL-NL2. Participants will wear the hearing aids for four weeks.

Timeline

• Start date: 2023-07-17
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2023-03-23
• Last updated: 2024-02-29

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated device study