Jabra Enhance Select Self-fit (Jabra Enhance Select 550)— 510(k) K254108

Name: FDA 510(k) clearance K254108
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

GN 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.

Clearance details

Applicant: GN Hearing A/S
Product code: Code QUH
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2025-12-19
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code QUH

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K233747 — Concha Sol Hearing Aids (CL-1001)2024-03-15
K233464 — WSA Self-Fitting Hearing Aid Gen 22024-02-09
K231550 — Sontro® OTC Hearing Aids (AI)2023-10-26
K221052 — Self-Fitting hearing aids2023-09-25
K223848 — Intrisound Tuned Lumen® 155 Hearing Aids2023-09-08

More clearances from GN Hearing A/S

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K213424 — Jabra Enhance Plus2022-01-19
K193303 — Tinnitus Sound Generator Module2020-02-20
K180495 — Tinnitus Sound Generator Module2018-11-30
K181586 — Tinnitus Sound Generator Module2018-07-13

Adverse events under product code QUH

product code QUH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.