510(k) K223848
K223848 is an FDA 510(k) premarket notification submitted by Tuned , Ltd. for the device "Intrisound Tuned Lumen® 155 Hearing Aids". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code QUH (Self-Fitting Air-Conduction Hearing Aid, Over The Counter), a Class II device regulated under 21 CFR 874.3325. Tuned , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2023
- Date Received
- December 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- Device Class
- Class II
- Regulation Number
- 874.3325
- Review Panel
- EN
- Submission Type
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.