Serenity Tinnitus Masker
510(k) K150014
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150014 | Date27 Jul 2015 | 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- Withdrawn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
- Full name
- Serenity
- 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
The Serenity Tinnitus Masker is a sound enrichment therapy device designed to mitigate tinnitus symptoms. Classified as a Masker, Tinnitus under FDA nomenclature (KLW product code), it delivers customizable sound therapy to help patients manage chronic ringing or noise perception in the ears. This device operates within Class II regulatory classification, adhering to FDA standards for ear, nose, and throat applications.
Prescribed by hearing healthcare professionals, the Serenity device is programmed to generate tailored sound profiles for individual patients. Supplied as a reusable medical device, it requires no sterilization and is intended for use in clinical or home settings. Authorized under FDA 510(k) clearance (K150014), it complies with regulation 21 CFR 874.3400 for tinnitus treatment devices. No MRI safety or sterility requirements are specified in the regulatory submission.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Serenity Tinnitus Masker and how is it prescribed?
The Serenity Tinnitus Masker is designed to provide sound enrichment therapy for patients experiencing chronic tinnitus, which is the perception of ringing or noise in the ears. It is prescribed by hearing healthcare professionals who customize sound profiles for individual patients to help manage their symptoms. The device is intended for use in both clinical and home settings, offering tailored auditory stimulation to alleviate tinnitus discomfort.
Is the Serenity device reusable, and if so, what maintenance or cleaning is required?
Yes, the Serenity Tinnitus Masker is supplied as a reusable medical device. Since it does not require sterilization, maintenance typically involves routine cleaning as recommended by the manufacturer to ensure proper functionality and hygiene. No specific sterilization procedures are mentioned in the regulatory documentation, so adherence to general device care guidelines is advised.
How is the regulatory status of the Serenity device determined, and what does this mean for clinicians?
The Serenity Tinnitus Masker is classified under FDA’s Class II regulatory category and holds a 510(k) clearance (K150014) for tinnitus treatment devices, specifically under product code KLW. This means it has been deemed *substantially equivalent* to a legally marketed predicate device and complies with FDA standards for ear, nose, and throat applications. Clinicians can rely on this clearance as evidence of its safety and effectiveness for prescribed use in managing tinnitus symptoms.
Are there any size or model variations for the Serenity device, and how might this affect patient selection?
The provided data does not specify distinct size or model variations for the Serenity device, but it lists multiple registration numbers (e.g., 3010197022, 3003426343, etc.) under OpenFDA, which may correspond to different configurations or software versions. These variations could influence programming flexibility for tailored sound therapy. Clinicians should confirm compatibility with patient needs or consult the manufacturer for specific model details.
Does the Serenity device have any restrictions on use, such as MRI safety or environmental conditions?
The regulatory submission for the Serenity Tinnitus Masker does not mention any MRI safety requirements, meaning it is not explicitly labeled for or against MRI environments. Additionally, no sterility requirements are specified, implying standard hygiene practices are sufficient. Storage should follow manufacturer guidelines to preserve functionality, though no environmental restrictions (e.g., temperature, humidity) are detailed in the provided data.