By brand

Apple

2 products in our database · Average MSRP $249

FDA regulatory pathways in this brand

FDA-cleared OTC hearing aid software

FDA-cleared OTC hearing aid software (Class 2, 21 CFR 874.3335, product code SCR)

New to these labels? All 9 FDA pathways, decoded in plain English.

Available products

Sorted by price (low to high). All pricing verified July 2026.

Apple

AirPods Pro 2 with Hearing Aid Feature

FDA-cleared OTC hearing aid software

Severity range: 26–60 dB HL
Form factor: earbud-style
Battery: Rechargeable (6 hr)
Bluetooth: Apple H2 chip — pairs with iPhone/iPad on latest iOS/iPadOS
Trial: 14 days
Warranty: 12 months

FDA De Novo classification (DEN230081, product code SCR) — software is the cleared device, AirPods Pro 2 hardware is the supported platform. Requires latest iOS/iPadOS on iPhone or iPad.

Apple

AirPods Pro 3 with Hearing Aid Feature

FDA-cleared OTC hearing aid software

Severity range: 26–60 dB HL
Form factor: earbud-style
Battery: Rechargeable (10 hr)
Bluetooth: Apple H2 chip (3rd gen), improved transparency mode
Trial: 14 days
Warranty: 12 months

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.