Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1450042

FEI Number

1450042

Entity Name

ETYMOTIC RESEARCH, INC.

City/State/Country

Schaumburg, IL, US

Establishment Address

1125 Remington Road, Schaumburg, IL 60173, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ETYMOTIC RESEARCH, INC. (Owner Number: 1450042)

Owner / Operator Contact Address

1125 Remington Rd, --, Schaumburg, IL 60173, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Enlite ER-3C Insert Earphones ER-3A Insert Earphones Lucid Portable Charging Case Lucid Rechargeable Battery Module Renew Accent fio TALA ER3-14 Eartips, ER38-14 Eartips, ER38-15 Eartips, ER38-18 Eartips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-11-02
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2008-11-26
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2020-02-11
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2022-11-02
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	Class 1	874.1100	1992-06-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ETYMOTIC RESEARCH, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
3016157573	ZHUHAI ZOROSY TECHNOLOGY CO., LTD.	Zhuhai Guangdong, CN
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3027300374	SHENZHEN AKAUDIO CO., LIMITED	Shenzhen Guangdong, CN
3033659461	SHENZHEN SOUNDS GOOD TECHNOLOGIES CO., LTD	Shenzhen Guangdong, CN
3008460009	Shenzhen Zhongde Audio-Technical Co., Ltd.	Shenzhen City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450042. Last updated year: 2026. Please use registration number 1450042 when referencing this establishment in official correspondence.