QUH — Self-Fitting Air-Conduction Hearing Aid, Over The Counter Class II

FDA Device Classification

Classification Details

Product Code
QUH
Device Class
Class II
Regulation Number
874.3325
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233747concha labsConcha Sol Hearing Aids (CL-1001)March 15, 2024
K233464wsaudWSA Self-Fitting Hearing Aid Gen 2February 9, 2024
K231550soundwave hearingSontro® OTC Hearing Aids (AI)October 26, 2023
K221052huizhou jinghao medical technology coSelf-Fitting hearing aidsSeptember 25, 2023
K223848tunedIntrisound™ Tuned Lumen® 155 Hearing AidsSeptember 8, 2023
K230538sonovaAll-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidJune 16, 2023
K223137hearx sa (pty)Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationMarch 14, 2023
K221698eargoEargo 5 , Eargo 6December 21, 2022
K221064nuheara limitedNuheara IQbuds 2 PRO Hearing AidOctober 30, 2022