Interacoustics AT22T Automatic Impedance Audiometer
by Idem (Int'L Dist. of Electronics For Medicine)
510(k) K990585
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990585 | Date17 May 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ETY
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.1090
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Interacoustics AT22T Automatic Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals for conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.
The device is supplied by Idem (Int'L Dist. of Electronics For Medicine) and is classified as a Tester, Auditory Impedance with product code ETY. It received FDA 510(k) clearance with number K990585 on May 17, 1999, as substantially equivalent to predicate devices. The device is intended for use in ear, nose, and throat diagnostic settings.
Other devices from Idem (Int'L Dist. of Electronics For Medicine)
Questions
AI-generated answers, 6 Oct 2026
What is the Interacoustics AT22T Automatic Impedance Audiometer used for?
The AT22T is an electroacoustic test instrument that produces controlled levels of test tones and signals for conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry capabilities.
How is the Interacoustics AT22T supplied and what is its regulatory status?
The device is supplied by Idem (Int'L Dist. of Electronics For Medicine) and received FDA 510(k) clearance with number K990585 on May 17, 1999, as substantially equivalent to predicate devices. It is intended for use in ear, nose, and throat diagnostic settings.
What are the key features of the Interacoustics AT22T Automatic Impedance Audiometer?
The AT22T is classified as a Tester, Auditory Impedance with product code ETY. It provides comprehensive testing capabilities including tympanometry, acoustic reflex testing, and air conduction audiometry to support diagnostic evaluations in audiology and otology practices.