ETY · Tester, Auditory Impedance
Ear, Nose, Throat · 21 CFR 874.1090 · Class 2
Overview
| Product Code | ETY |
|---|---|
| Device Name | Tester, Auditory Impedance |
| Regulation | 21 CFR 874.1090 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.
Classification Rationale
Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (20 of 70)
Showing 20 most recent of 70 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | Mar 6, 2019 | SESE |
| K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | Aug 2, 2017 | SESE |
| K162210 | touchTymp | Maico Diagnostics GmbH | Nov 16, 2016 | SESE |
| K161707 | Madsen Zodiac | Gn Otometrics | Sep 1, 2016 | SESE |
| K151616 | AT235 | Interacoustics A/S | Jul 15, 2015 | SESE |
| K151509 | GSI TympStar Pro Middle Ear Analyzer | Diagnostic Group, Dba Grason-Stadler | Jun 25, 2015 | SESE |
| K133013 | INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE | Inventis S.R.L. | Jan 24, 2014 | SESE |
| K121847 | TITAN | Interacoustics A/S | Nov 29, 2012 | SESE |
| K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE | Interacoustics AS | Apr 9, 2009 | SESE |
| K081841 | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | Amplivox, Ltd. | Jul 16, 2008 | SESE |
| K070312 | EARCHECK ACOUSTIC REFLECTOMETER | Innovia Medical, LLC | Mar 2, 2007 | SESE |
| K033645 | OTOFLEX 100 TYE 1012 | Gn Otometrics A/S | Mar 31, 2004 | SESE |
| K031978 | AMPLAID A756 SCREENING ADMITTANCE METER | Amplaid | Jul 21, 2003 | SESE |
| K022728 | AUDIOTRAVELLER, MODEL AA222 | Interacoustics A/S, Assens | Oct 11, 2002 | SESE |
| K000097 | GSI 2000 MIDDLE EAR ANALYZER | Grason-Stadler, Inc. | Apr 12, 2000 | SESE |
| K994254 | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER | International Distributors of Electronics For Medi | Mar 14, 2000 | SESE |
| K991562 | PASCAL MEDICAL AB MENIETT 20 | Pascal Medical AB | Dec 28, 1999 | SESE |
| K992370 | AMPLAID A724 AND A728 | Amplifon S.P.A. | Sep 20, 1999 | SESE |
| K990652 | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | May 17, 1999 | SESE |
| K990585 | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | May 17, 1999 | SESE |
Top Applicants
- American Electromedics Corp. — 12 clearances
- Maico Hearing Instruments, Inc. — 5 clearances
- Teledyne Avionics Div. of Teledyne — 5 clearances
- Idem (Int'L Dist. of Electronics For Medicine) — 3 clearances
- Madsen Electronics (Canada) , Ltd. — 3 clearances
