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.

Eargo 8 · Self-Fitting Air-Conduction Hearing Aid, over the Counter → Ear Nose & Throat

Name: Eargo 8
Brand: Eargo 8

4manufacturers in China registered for this device type

11catalogue numbers in this listing

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 Eargo 8
Listed by	Eargo Inc, United States
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	Complaint-file establishment, Manufacturer
510(k)	K221698
Record published	2025-05-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Eargo 8
Catalogue number	Size	Status
99-0187-001		In distribution
99-0185-001		In distribution
99-0180-001		In distribution
99-0186-001		In distribution
99-0196-001		In distribution
99-0184-001		In distribution
99-0193-001		In distribution
99-0179-001		In distribution
99-0179-001-U		In distribution
99-0182-001		In distribution
99-0181-001		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
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
hear.com	WS Audiology USA, Inc.	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
K221698	2022-12-21

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.

Eargo 8