Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 25, 2024
Date Accepted: Jul 31, 2024
Over-the-counter hearing aid versus traditional hearing aid in patients with mild-to-moderate hearing loss: protocol for a randomized controlled, non-inferiority trial
ABSTRACT
Background:
With the aging of society, the prevalence of hearing loss (HL) is increasing. Currently, approximately 5% of the global population has HL, and this number is projected to reach seven million by 2050. Although hearing aids (HAs) are the primary treatment for HL, their use is limited by barriers such as high costs and social stigma. To address these limitations, over-the-counter (OTC) HAs have been introduced, but their effectiveness and drawbacks require further investigation.
Objective:
The purpose of this study is to conduct a non-inferiority randomized controlled trial (RCT) comparing OTC HAs with traditional HAs to assess the clinical effectiveness of OTC HAs.
Methods:
We designed a non-inferiority RCT comparing OTC hearing aids and traditional HAs in adults with mild-to-moderate HL. A total of 56 participants (28 per group) will be recruited. Randomization will be performed using block randomization (block sizes of 2 or 4) with an equal allocation ratio. The study will include two types of HAs: OTC HA (Jabra Enhance Pro) and traditional HA (LiNX Quattro LE561-DRW) by GN ReSound A/S. OTC HAs will be self-fitted using a smartphone app, while traditional HAs will be fitted by a licensed audiologist using the NAL-NL2 prescription. Assessments, including functional gain, real-ear measurement, speech audiometry, and questionnaires, will be conducted at three-month intervals over the course of three visits. Statistical analysis will compare the two H' outcomes, focusing on functional gain, to determine non-inferiority.
Results:
.
Conclusions:
Since 2022, the introduction of OTC HAs has revolutionized access to these devices. Researchers, clinicians, and the general public are keen to evaluate the clinical effectiveness of OTC HAs, as more individuals will likely utilize them for HL. This increased usage will provide valuable real-world data to understand the benefits and limitations of OTC HAs. Monitoring the outcomes and user feedback will provide insights into their effectiveness and impact on hearing rehabilitation. Clinical Trial: Clinical Research Information Service (https://cris.nih.go.kr/) KCT0008666. Registered on August 01, 2023.
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