DeviceClearance

Product code QDD— Ear, Nose, Throat

BHA100 Series Braun Clear Hearing Aid

Classification name
Self-Fitting Air-Conduction Hearing Aid, Prescription
Device class
Class 2
Regulation
21 CFR 874.3325
Advisory panel
Ear, Nose, Throat
Total cleared
7
First cleared
Most recent

FDA classification definition

“A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.”

— U.S. Food and Drug Administration, device classification record for product code QDD under 21 CFR 874.3325, via openFDA

Market context for product code QDD

FDA has cleared 7 devices under product code QDD between 2018 and 2023, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QDD

Recent clearances under product code QDD

Data sourced from openFDA. This site is unofficial and independent of the FDA.