The 2022 FDA rule change

For decades, hearing aids were regulated as prescription medical devices — you needed an audiologist or hearing instrument specialist to evaluate your hearing, recommend a device, and fit it. This requirement kept prices high and access limited.

In August 2022, the FDA finalized a rule creating a new category: over-the-counter (OTC) hearing aids. Adults 18 and older with perceived mild-to-moderate hearing loss can now buy hearing aids directly from retailers — pharmacies, electronics stores, and online — without any professional involvement.

Who qualifies for OTC hearing aids

OTC hearing aids are intended for adults (18+) who perceive they have mild-to-moderate hearing loss. The FDA does not require a hearing test to purchase OTC aids — the determination is self-assessed.

However, the FDA recommends seeing a doctor before buying OTC aids if you experience any of the following:

• Hearing loss that came on suddenly or rapidly
• Hearing loss in only one ear
• Ear pain, drainage, or bleeding
• Dizziness or balance problems
• Visible ear deformity or blockage
• Hearing loss in a child under 18

These signs may indicate a medical condition requiring treatment — not just amplification.

OTC vs. prescription: key differences

• Price — OTC aids cost $300–$1,650/pair; prescription aids cost $2,000–$7,500/pair
• Fitting — OTC aids are self-fitted via app; prescription aids are professionally fitted to your audiogram
• Technology — prescription aids have more advanced processing, more channels, and better AI
• Hearing loss range — OTC aids are designed for mild-to-moderate loss only; prescription aids cover all degrees
• Follow-up care — prescription aids include professional follow-up; OTC aids are self-managed
• Trial periods — OTC aids often have longer trial periods (45–100 days vs. 30–45 days for prescription)

Best OTC hearing aids

The leading OTC options include Jabra Enhance Plus (best overall, earbud-style), Eargo 7 (best invisible), Sony CRE-10 (simplest, no app needed), Lexie Lumen (best budget with Bluetooth), and Audien Atom Pro (lowest price). Each has different strengths — see our full OTC section for detailed comparisons.

Should you skip the audiologist?

OTC aids are a genuine option for mild-to-moderate loss — especially for people who've been putting off hearing aids due to cost or inconvenience. But a professional hearing evaluation has real value: it identifies the type and degree of your loss, rules out medical causes, and ensures you're getting the right amplification for your specific hearing profile.

If you try OTC aids and aren't satisfied with the results, that's often a sign that professional fitting — and possibly a prescription device — would serve you better.