Self-Fitting Air-Conduction Hearing Aid, Prescription
The Self-Fitting Air-Conduction Hearing Aid, Prescription is a wearable sound amplifying device intended to compensate for impaired hearing, incorporating software technology that allows users to independently program, derive, and customize their hearing aid fitting and settings; it requires a prescription. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QDD under regulation 874.3325 in the Ear, Nose, and Throat specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDD
- Device Class
- FDA class 2
- Regulation Number
- 874.3325
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223911 | Lumen 155-SF | Oct 17, 2023 | Substantially Equivalent | Intricon Corporation |
| K220403 | Vibe SF Self-Fitting Hearing Aid | Aug 12, 2022 | Substantially Equivalent | Wsaud A/S |
| K220303 | MDHearingAid app, MDHearingAid Smart hearing aids | Aug 04, 2022 | Substantially Equivalent | Mdhearingaid |
| K213424 | Jabra Enhance Plus | Jan 19, 2022 | Substantially Equivalent | GN Hearing A/S |
| K212609 | BHA100 Series Braun Clear Hearing Aid | Jan 05, 2022 | Substantially Equivalent | Kaz USA, Inc., A Helen of Troy Company |
| K211008 | Bose SoundControl Hearing Aids | May 05, 2021 | Substantially Equivalent | Bose Corporation |
| DEN180026 | Bose Hearing Aid | Oct 05, 2018 | Unknown | Bose Corporation |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.