Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2523819

FEI Number

2523819

Entity Name

MICROSONIC, INC.

City/State/Country

AMBRIDGE, PA, US

Establishment Address

2960 DUSS AVE., AMBRIDGE, PA 15003, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Microsonic, Inc. (Owner Number: 2523819)

Owner / Operator Contact Address

2960 Duss Ave., Ambridge, PA 15003, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K950912

PMA Number

N/A

All Registered Proprietary Names

#12 Standard Tube, #13 Medium Tube, #13 Thick Tube, #13 Double Wall Tube Acrylic with Vinylflex Canal, Acrylic with Synth-A-Flex Canal Tube Lock, Tube Lock Plus, Gold Lock, Silver Lock, Invisilock Open Fit Earmold, Slim Fit Earmold, Polyethylene Earmold, PassGuard Earmold MikroLok Medi-Sil, Super Alerite, Acrylic Earmold Addition Supra Plus Swim Plug, Neon Lite, Micro Canal, Microshell M2000, M2000 Plus, Synth-A-Flex, Vinylflex Single Bend, Solo Bend, Double Bend Dri-Tube Moisture-Free Tubes, Vibrant Color Tube, Gold Lock DW, Alerite Body with Silicone Canal M2000 Neon Lites LifePlugs Sound Defenders PassGuard Musicians Earplugs ER Plugs SoftGuard AgileEars Swim Plugs Mega-Sil Silasoft

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2013-05-09
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2016-11-16
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2007-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Microsonic, 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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN
1056339	EAR TECHNOLOGY CORPORATION	Johnson City, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2523819. Last updated year: 2026. Please use registration number 2523819 when referencing this establishment in official correspondence.