Jabra Enhance Select Self-fit (Jabra Enhance Select 550)— 510(k) K254108
Substantially EquivalentGN Hearing A/S
FDA 510(k) clearance K254108 for Jabra Enhance Select Self-fit (Jabra Enhance Select 550), Substantially Equivalent on 2026-06-25. Applicant: GN Hearing A/S. Device class: 2.
Summary
GN Hearing's Jabra Enhance Select Self-fit (model Jabra Enhance Select 550) is filed under QUH, over-the-counter self-fitting air-conduction hearing aids. The record doesn't describe it beyond the model name and the code name.
Class II, 21 CFR 874.3325. Ear, Nose, and Throat is both the classification panel and the review panel, and the submission was a Traditional 510(k).
GN Hearing filed from Ballerup, Denmark. Review took 188 calendar days (December 19, 2025 to June 25, 2026).
Clearance details
- Applicant
- GN Hearing A/S
- Product code
- Product code QUH
- Device class
- Class 2
- Regulation
- 21 CFR 874.3325
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ballerup, DK
Recent devices under product code QUH
view allMore clearances from GN Hearing A/S
view allAdverse events under product code QUH
product code QUH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.