aTymp

Basic Information

• Brand Name: aTymp
• Primary DI: 04650075334003
• Version / Model: aTymp
• Company Name: NEUROSOFT, OOO
• Labeler DUNS: 643212926
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-02
• Public Version: 1
• Public Version Date: 2023-02-10
• Public Version Status: New
• Public Device Record Key: a4179687-db01-4bcd-b408-070923d72639

Device Description

The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders with the help of acoustic impedance tests, including tympanometry, Eustachian tube function (for intact and perforated tympanic membrane), acoustic reflex and acoustic reflex decay. The target population for aTymp system includes all ages. During the Eustachian tube function tests patient should be able to understand and perform instructions to do maneuvers.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PTP	Tympanometer, Exempt	Ear, Nose, Throat	874.1090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58019	Otoacoustic emission system, battery-powered	An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04650075334003	GS1