Do you have hearing loss? Symptoms include difficulty hearing in noisy places, following group conversations, or needing to increase TV volume. In August 2022, the FDA authorized OTC hearing aids for adults 18+ with perceived mild to moderate hearing loss, allowing purchase without a medical exam or audiologist fitting.
January 11, 2025

OTC Hearing Aids: What You Need to Know

Evidence-Based Over-the-Counter Guide

William Shen

William Shen

Co-founder & CPO

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In August 2022, the U.S. Food and Drug Administration (FDA) established a new category of over-the-counter (OTC) hearing aids, allowing adults aged 18 and older with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online without the need for a medical exam, prescription, or fitting by an audiologist.

Symptoms suggesting perceived mild to moderate hearing loss:

  • You have trouble hearing speech in noisy places

  • You find it hard to follow speech in groups

  • You have trouble hearing on the phone

  • Listening makes you tired

  • You need to turn up the volume on the TV or radio, and other people complain it’s too loud

These OTC hearing aids are air-conduction devices intended to amplify sound for individuals with perceived mild to moderate hearing loss. They enable users to control and customize device settings to their hearing needs through tools, tests, or software, and may incorporate wireless technology or self-assessment features.

Device options include:

  • Legacy/Wireless Hearing Aids: Basic features like volume control and preset programs.

  • Self-Fitting Hearing Aids: Enhanced customization with hearing tests, software, and apps, with or without wireless capabilities.

Hearing test: Apple Hearing Test, available on its AirPods Pro 2 , can show you have hearing loss and shows your hearing ability at different frequencies of sound measured in decibels hearing level (dBHL). It can also serve as a hearing aid with a free software update as of FDA Approval in September 2024.

Recommended FDA-cleared OTC hearing aids:

  • All round quality: Eargo SE Self-Fitting Hearing Aids (FDA Reg. 874.3325). Best reviewed FDA-cleared hearing aid available on Amazon.

  • Best invisible fit: Sony CRE-C20 (FDA Reg. 874.3325). These aids slip completely into your ear for a look that’s basically invisible. 

  • Most economical: Apple AirPods Pro 2 with free software update (21 CFR 874.3335). In September 2024, the FDA authorized the first over-the-counter hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.

Citations:

Food and Drug Administration. 2023. OTC Hearing Aids: What You Should Know.

What OTC evidence is reviewed?

  • For each condition, we performed a literature review to find a recent widely cited expert group guideline published in the leading specialty-specific peer-reviewed journal or top general medical journal.

  • Based on the recommendations in the publication, we identify recommended active ingredients and devices that are available over-the-counter per FDA regulations.

What evidence is prioritized?

Levels of evidence considered:

  • Tier 1 (Safe and Definitely Effective): Professional field consensus or multiple randomized controlled clinical trials showing the same conclusion. Wherever possible, we use Tier 1 evidence for "first-line" recommendations.

  • Tier 2 (Safe and Probably Effective): Individual clinical trials which may be discordant or large-scale observational experience. Tier 2 evidence may inform "first-line", "second-line", or "supplement" recommendations.

  • Tier 3 (Safe and Maybe Effective): Mechanistic plausibility without high-quality clinical evidence of efficacy but high-quality evidence of safety. Tier 3 evidence may inform "second-line" or "supplement" recommendations.

How does MDandMe select recommended products?

  • Based on the top clinical recommendation, we evaluate products containing the recommended active agent with FDA-approved dosage based on price, average customer reviews, how often it is purchased, and how quickly it will ship to home. 

  • We provide public documentation of the active ingredients in our recommendations, using all 32 FDA monographs, Prescription-to-Nonprescription (Rx-to-OTC) Switches, as well as New Drug Application (NDA) approvals.

How does MDandMe select recommended devices?

  • Based on the top clinical recommendation, we evaluate devices that are FDA-cleared or comply with other medical guidelines (if not a FDA-regulated category) by reputability, price, and average customer reviews.

  • We provide public documentation of supporting evidence for each device.  

Where do I view other OTC guides?

Browse topic list here:

You can view all of our published OTC guides here.

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