Over-the-Counter Hearing Aids Versus Traditional Hearing Aids in Patients With Mild-to-Moderate Hearing Loss: Protocol for a Noninferiority Randomized Controlled Trial

Over-the-Counter Hearing Aids vs. Traditional Hearing Aids

Background

Hearing loss (HL) is becoming more common, affecting about 5% of people worldwide. This number could reach 7 million by 2050. Traditional hearing aids (HAs) are the main treatment but are often too expensive or carry social stigma. Over-the-counter (OTC) HAs are a new option, but we need to study how well they work compared to traditional HAs.

Objective

This study will compare the effectiveness of OTC HAs with traditional HAs to see if OTC HAs are just as good.

Methods

We will conduct a randomized controlled trial with 64 adults who have mild-to-moderate HL. Participants will be divided into two groups: one using OTC HAs (Jabra Enhance Pro) and the other using traditional HAs (LiNX Quattro LE561-DRW). OTC HAs will be fitted using a smartphone app, while traditional HAs will be fitted by a licensed audiologist. We will evaluate hearing improvement through various tests over a year with three visits.

Results

The study will start in August 2024 and will run for two years, with each participant having follow-up visits every six months.

Conclusions

The introduction of OTC HAs in 2022 has made these devices more accessible. There is a strong interest in understanding how effective OTC HAs are, as more people are likely to use them. Collecting real-world data will help us learn about their benefits and challenges.

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