← Back to catalogue

Jabra Enhance Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213424

by Gn Hearing A/S

Identifiers

510(k) Number
K213424 FDA 510(k)
FDA Product Code
QDD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.3325 FDA 510(k)
Regulation Number
874.3325 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Self-Fitting Air-Conduction Hearing Aid, Prescription. This device is classified as a Class II medical device under regulation number 874.3325 and product code QDD. It is substantially equivalent to a legally marketed device and was cleared via the traditional 510(k) pathway.

The device is intended for use in the Ear, Nose, Throat medical specialty. It is supplied as a prescription hearing aid and requires user fitting via the Jabra Enhance app for iOS devices. Storage, handling, and use should follow the manufacturer's user manual. No information on sterility, single-use or reusable status, MRI safety, or specific sizes is provided in the data.

Frequently asked questions

What is the Jabra Enhance Plus intended for?

The Jabra Enhance Plus is intended for use as a self-fitting air-conduction hearing aid requiring prescription and is designed for individuals needing hearing assistance in the Ear, Nose, Throat medical specialty, as indicated by its FDA classification under regulation 874.3325 and product code QDD.

How is the Jabra Enhance Plus supplied and fitted?

The device is supplied as a prescription hearing aid and requires user fitting via the Jabra Enhance app for iOS devices, meaning it is not ready-to-wear out of the box and depends on software-based personalization through a compatible Apple mobile platform.

What regulatory pathway was used to clear the Jabra Enhance Plus?

The Jabra Enhance Plus was cleared via the traditional FDA 510(k) pathway under k-number K213424, demonstrating substantial equivalence to a legally marketed predicate device, which is the standard route for moderate-risk Class II medical devices like this hearing aid.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF ENHANCE PLUS Engineered for world-class hearing enhancement ... - Jabra, Get support for Jabra Enhance Plus, PDF Manufacturer: USER MANUAL - Jabra Enhance, GN JABRA ENHANCE PLUS USER MANUAL Pdf Download

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gn Hearing A/S

Sources (1)

  • FDA 510(k) K213424 24 fields · synced Oct 1, 2026