Evok 900 Series Hearing Aid/Tinnitus Masker
by Magnatone Hearing Aid Corp. dba Persona Medical
510(k) K093715
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093715 | Date22 Dec 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Evok 900 Series Hearing Aid/Tinnitus Masker Option Device
- 510(k) Number
- FDA Product Code
- KLW
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.3400
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Evok 900 Series is a hearing aid and tinnitus masker, classified as a masker under FDA regulation 874.3400. It combines air conduction hearing assistance with an integrated broad-band noise generator to provide therapeutic masking for tinnitus. Designed for custom and standard fittings, the device incorporates digital signal processing to deliver adjustable sound therapy and hearing amplification.
Supplied as a reusable, non-sterile medical device, the Evok 900 Series is intended for otolaryngological use. It features programmable memory settings, dynamic speech enhancement, and feedback suppression, with 12-band graphic equalizer controls. The device holds an FDA 510K clearance (K093715) under the Ear, Nose, and Throat advisory committee, classified as Class II. Storage and handling follow standard medical device protocols for hearing aids.
Questions
AI-generated answers, 1 Oct 2026
What is the Evok 900 Series designed to address?
The Evok 900 Series is a dual-function device designed to address both hearing loss and tinnitus. It provides air conduction hearing assistance through amplification while incorporating a broad-band noise generator to deliver therapeutic masking for tinnitus. This integrated approach allows clinicians to tailor sound therapy and amplification to the patient’s specific needs, improving both auditory clarity and comfort for tinnitus sufferers.
Is the Evok 900 Series reusable or single-use?
The Evok 900 Series is supplied as a reusable medical device. It is not intended for single-use and is designed to be maintained and recalibrated according to standard medical device protocols for hearing aids. Proper cleaning and storage are essential to ensure longevity and performance.
What customization options are available for the Evok 900 Series?
The device offers programmable memory settings, allowing clinicians to save and recall specific configurations for different patients or environments. It also includes dynamic speech enhancement and feedback suppression to optimize sound quality. The 12-band graphic equalizer provides fine-tuned control over frequency response, enabling precise adjustments for both hearing aid and tinnitus masker functions.
How should the Evok 900 Series be stored?
The Evok 900 Series should be stored in accordance with standard medical device protocols for hearing aids. This typically includes keeping the device in a clean, dry environment, away from direct sunlight or extreme temperatures, and using the manufacturer’s recommended storage case or container. Proper storage helps maintain device integrity and ensures reliable performance when in use.
What regulatory pathway does the Evok 900 Series follow?
The Evok 900 Series is classified under FDA regulation 874.3400 as a masker and holds an FDA 510(k) clearance (K093715) through the Ear, Nose, and Throat (EN) advisory committee. It is classified as a Class II device, indicating it has undergone review to demonstrate substantial equivalence to a predicate device. The clearance confirms its compliance with applicable safety and performance standards for otolaryngological use.