What is FDA product code QUH?

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.

Ear Nose & Throat › ProstheticSelf-Fitting Air-Conduction Hearing Aid, Over The Counter

All-Day Clear 1.0 App

Name: All-Day Clear 1.0 app
Brand: All-Day Clear 1.0 app

Catalogue number 088-5015, listed by Sonova AG, Switzerland, under Self-Fitting Air-Conduction Hearing Aid, Over The Counter. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code QUH
Manufacturer	City	Province	Registered as	Device types
Luxshare Electronic Technology (Kunshan) Ltd.	Kunshan	Jiangsu	Contract manufacturer	1
Maintek Computer (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	1
GN Resound China, Ltd.	Xiamen	Fujian	Contract manufacturer	7
Huizhou Jinghao Medical Technology Co., Ltd.	Huizhou	Guangdong	Contract manufacturer	5

Record

Regulatory record for All-Day Clear 1.0 app
Listed by	Sonova AG, Switzerland
FDA product code	QUH
Device type	Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Device class	Class 2
Regulation	21 CFR 874.3325
Establishment	Specification developer, Manufacturer
Record published	2023-02-16
Record revised	2026-04-15 (version 4)

Specifications

Specifications
MRI safety	MR Safe
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for All-Day Clear 1.0 app
Catalogue number	Size	Status
088-5015		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Eargo SE	Eargo Inc	16
Soundwave Hearing	Soundwave Hearing, LLC	14
GN Hearing	GN Hearing A/S	13
Sontro Self-Fitting OTC Hearing Aids	Soundwave Hearing, LLC	12
Eargo 5	Eargo Inc	12
Eargo 8	Eargo Inc	11
Lexie Hearing	Hearx SA	11
Sony	WS Audiology USA, Inc.	5
Eargo 6	Eargo Inc	3
Eargo 7	Eargo Inc	3
Sonova Brand (multiple brand)	Sonova AG	3
Audialnet	Huizhou Jinghao Medical Technology Co., Ltd.	2

Showing 12 of 28. All products under Self-Fitting Air-Conduction Hearing Aid, Over The Counter

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K230538	2023-06-16

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.