Apple
AirPods Pro 2 with Hearing Aid Feature
FDA-cleared OTC hearing aid software
By brand
Every hearing aid brand, FDA pathway labeled honestly
The OTC hearing aid market is built on regulatory ambiguity. Only some brands have actual OTC self-fit clearance. Others sell prescription devices as OTC under self-certification. Some are ride-on variants of a parent K-number. A few sell PSAPs (Personal Sound Amplifiers) marketed as hearing aids. We label each one honestly.
Per the FDA classification database (live-queried 2026-05-31), only ~13 OTC hearing aids have actual QUH (self-fit) or SCR (software) clearance under 21 CFR 874.3325 / 874.3335. The rest of the OTC market is pathway-ambiguous in some way.
Verified OTC self-fit (QUH or SCR primary)
Brands with their own FDA 510(k) clearance under product code QUH or De Novo under SCR. The cleanest pathway.
Apple
2 of 2 products with verified FDA pathway
Concha Labs
1 of 1 product with verified FDA pathway
Nuance Audio
Manufactured by Luxottica
1 of 1 product with verified FDA pathway
Nuheara
1 of 1 product with verified FDA pathway
Sennheiser
3 of 3 products with verified FDA pathway
Soundwave
1 of 1 product with verified FDA pathway
Tuned
1 of 1 product with verified FDA pathway
Mixed pathways (ride-on variant or Rx-cleared sold as OTC)
Brands whose product line includes ride-on variants of a parent K-number OR Rx-cleared (QDD) products self-certifying OTC compliance under 21 CFR 800.30.
Ambiguous pathway — FDA-registered only
Brands marketing 'FDA-registered Class I' products with no specific 510(k) under their name in openFDA. Establishment registration only. Pre-purchase, verify the K-number with the manufacturer.
PSAP-flagged
Brands selling Personal Sound Amplifiers marketed as or alongside hearing aids. PSAPs are regulated as consumer audio products, NOT medical devices. Suitable only for situational amplification, not for treating hearing loss.
Costco-exclusive prescription line
Sold only at Costco hearing aid centers. Not affiliate-eligible — we surface comparable OTC options on Amazon instead.
Skip the brand-by-brand reading — our picks
If you don't want to compare every brand, these three are the cleanest FDA-cleared OTC value across the lineup.
Best entry point
At $199 with FDA-cleared hearing aid software (DEN230081), the AirPods Pro 2 turn an iPhone you may already own into a legitimate mild-to-moderate hearing aid. Lowest-risk way to start.
Best dedicated OTC value
Lexie
B2 Plus Powered by Bose
Variant of parent K-number
Bose-tuned, rechargeable, self-fitting via the Lexie app, with a 45-day trial. $899 — a fraction of the audiologist price for the same mild-to-moderate range.
Best premium OTC
Sennheiser
All-Day Clear ADC1
FDA-cleared OTC self-fit
Built by Sonova (the company behind Phonak), the All-Day Clear is a true QUH self-fit hearing aid with Bluetooth streaming and a 2-year warranty — around $949 street.
Picks are based on FDA regulatory pathway, price, and severity fit from our verified product database — not on which brand pays the most.