510(k) K254108
K254108 is an FDA 510(k) premarket notification submitted by GN Hearing A/S for the device "Jabra Enhance Select Self-fit (Jabra Enhance Select 550)". The FDA issued a decision of Substantially Equivalent on June 25, 2026. The device falls under product code QUH (Self-Fitting Air-Conduction Hearing Aid, Over The Counter), a Class II device regulated under 21 CFR 874.3325. GN Hearing A/S has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2026
- Date Received
- December 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- Device Class
- Class II
- Regulation Number
- 874.3325
- Review Panel
- EN
- Submission Type
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 an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.