By brand
3 products in our database · Average MSRP $279
Some Audien products are PSAPs, not FDA-cleared hearing aids.
Personal Sound Amplifiers (PSAPs) are regulated as consumer audio products, not medical devices. They're suitable for situational amplification (hunting, lecture halls), not for treating hearing loss. The PSAP-labeled Audien products below have a red banner; do not buy them as a hearing aid replacement.
Traditional prescription hearing aid
Traditional prescription air-conduction hearing aid (Class 1, 21 CFR 874.3300, 510(k)-exempt). Dispensed via audiologist or Costco hearing aid center.
Personal Sound Amplifier — NOT a hearing aid
Personal Sound Amplifier (PSAP) — NOT an FDA-cleared hearing aid. PSAPs are regulated as consumer audio products, not medical devices.
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Sorted by price (low to high). All pricing verified June 2026.
Audien
Audien admits the EV1 is a Personal Sound Amplifier (PSAP), NOT an FDA-cleared hearing aid. Suitable only for situational amplification, not for treating hearing loss.
Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.
Audien
Audien admits EV3 is a Personal Sound Amplifier, NOT an FDA-cleared hearing aid. Situational amplification only.
Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.
Audien
Audien markets the Atom Pro 2 as 'Class I FDA-registered OTC.' However, MAUDE adverse-event records classify it under product code ESD (traditional Rx air-conduction hearing aid). No 510(k) exists under Audien's name in openFDA. The pathway is materially different from FDA-cleared OTC self-fit (QUH). At its $289 street price, it competes against Lexie Lumen ($299, QUH-cleared) and Apple AirPods Pro 2 HAF ($199, SCR-cleared) — both with significantly stronger regulatory backing.
Affiliate disclosure: we may earn a commission if you purchase through these links, at no extra cost to you.
Other ways to find your hearing aid
Run your audiogram through the interpreter for personalized device-class + product matches. Identify your Costco Kirkland if you already own one. Browse by severity if you know your PTA.