Multiflex Tinnitus Technology
510(k) K122876
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122876 | Date31 Oct 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 19 Sep 2026
Multiflex Tinnitus Technology is a tinnitus management software program integrated into hearing aids that helps patients with changing tinnitus needs. It provides an effective part of sound therapy and is designed to deliver tinnitus relief.
The device is supplied as software within hearing aids and is based on the patient's audiogram, with default output settings of broadband noise across 16 bands at the same acoustic level. It is authorized under FDA 510K with K122876 and is classified as a Class II device for Masker, Tinnitus.
Other devices from Starkey Laboratories Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of hearing aids does the Multiflex Tinnitus Technology work with, and how is it customized for each patient?
The Multiflex Tinnitus Technology is integrated into hearing aids as software, meaning it is designed to work with compatible Starkey hearing aid models. Customization is based on the patient’s audiogram, allowing the device to tailor broadband noise output across 16 frequency bands to match their specific tinnitus needs. This ensures the sound therapy is personalized for optimal relief.
Is the Multiflex Tinnitus Technology intended for one-time use or can it be reused with multiple patients?
The technology is embedded within hearing aids as software, which means it is not a standalone disposable device. Since it is integrated into the hearing aid hardware, it is intended for individual patient use and cannot be reused across multiple patients. Each patient’s settings are customized based on their audiogram, ensuring personalized care.
What is the default sound profile for the Multiflex Tinnitus Technology, and how does it function?
The default output setting delivers broadband noise across 16 frequency bands at the same acoustic level. This approach provides a consistent sound therapy profile to help mask tinnitus symptoms, though adjustments can be made based on the patient’s audiogram to refine the experience.
How is the Multiflex Tinnitus Technology regulated, and what does that mean for clinicians?
The device is authorized under the FDA’s 510(k) pathway (K122876) and classified as a Class II device for tinnitus maskers. This means it has undergone FDA review to ensure safety and effectiveness as a sound therapy tool for tinnitus management, providing clinicians with confidence in its regulatory standing.
Are there multiple versions or models of the Multiflex Tinnitus Technology, and if so, how do they differ?
The technology is not described as having distinct physical models but is instead integrated into various hearing aid models, each identified by unique registration numbers in the FDA database. The differences lie in the compatibility with specific Starkey hearing aid platforms rather than separate versions of the tinnitus software itself.