AT235

K151616 · Interacoustics A/S · ETY · Jul 15, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K151616
• Device Name: AT235
• Applicant: Interacoustics A/S
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Jul 15, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1090
• Device Class: Class 2

Intended Use

The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

Device Story

Auditory impedance analyzer; changes air pressure in external auditory canal; measures/graphs tympanic membrane mobility to evaluate middle ear function; detects abnormalities (stiffness, flaccidity, pathologies); measures acoustic reflex threshold via stapedial muscle contraction; includes basic air conduction audiometry. Used in clinical settings by audiologists, hearing healthcare professionals, or trained technicians. Device controls probe tone/pressure stimuli, measures results, and presents data on built-in display. No automated interpretation of results; operator interprets all data. Output assists in diagnosing otologic disorders, assessing central vs. peripheral pathologies, and determining uncomfortable loudness levels for rehabilitative amplification management.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, design verification, and validation according to medical device safety, EMC, and performance standards for impedance testers.

Technological Characteristics

Software-controlled auditory impedance tester; performs tympanometry, acoustic reflex, and air conduction audiometry. Complies with ANSI S3.39 for auditory impedance testers. Features built-in display for data presentation. Operates via probe tone and pressure stimuli control.

Indications for Use

Indicated for patients requiring diagnostic hearing evaluations and assessment of otologic disorders; features tympanometry, acoustic reflex, and air conduction audiometry.

Regulatory Classification

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.

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.

Predicate Devices

• AT235 (K994254)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2015

Interacoustics A/S c/o Mr. Eric Nielsen Director, Regulatory & Compliance Drejervaenget 8 5610 Assens Denmark

#### Re: K151616

Trade/Device Name: AT235 Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: June 11, 2015 Received: June 15, 2015

#### Dear Mr. Nielsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K151616

Device Name AT235

Indications for Use (Describe)

The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(K) SUMMARY

### AT235

| Company Name |
|--------------|
| Address |

Telephone Fax e-mail Contact Person Interacoustics A/S Drejervaenget 8 5610 Assens Denmark [phone] [phone] [e-mail] Erik Nielsen, Director, Regulatory & Compliance, June 12, 2015

Date Summary Prepared

#### Device Identification:

- Trade Name Common Name Classification Name Product Code Panel Device Class
AT235 Audiometric equipment Tester, Auditory Impedance ETY Ear Nose & Throat Class II (According to 21 CFR 874.1090)

## Predicate Devices:

Predicate Device Manufacturer 510(k) No. Date Cleared

AT235 Interacoustics K994254 03/14/2000

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| Device Description | AT235 is an auditory impedance analyser. The device is intended to<br>change the air pressure in the external auditory canal and measure<br>and graph the mobility characteristics of the tympanic membrane<br>to evaluate the functional condition of the middle ear. The device is<br>used to determine abnormalities in the mobility of the tympanic<br>membrane due to stiffness, flaccidity, or the presence of middle ear<br>pathologies. The device is also used to measure the acoustic reflex<br>threshold which occurs due to contractions of the stapedial muscle<br>following exposure to a strong stimulus.<br>This test allow to assess between central and peripheral<br>pathologies and to identify where the patients uncomfortable<br>loudness level may reside. The uncomfortable loudness level is<br>useful when providing rehabilitative amplification methods and<br>determining the correct management process for the patient.<br>The AT235 also includes basic audiometry functions.<br>The instrument is software controlled. The software controls the<br>probe (tone and pressure) stimuli, measures the result and<br>presents the result on a built in display. All functions are set and<br>interpreted by the operator (There are no interpretations of results<br>in the device). The technological characteristics are substantially<br>equivalent with predicate device. All technological characteristics<br>are in compliance with the consensus standard ANSI S3.39 for<br>auditory impedance testers |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Interacoustics AT235 Impedance Audiometer is an<br>electroacoustic test instrument that produces controlled levels of<br>test tones and signals intended for use in conducting diagnostic<br>hearing evaluations and assisting in the diagnosis of possible<br>otologic disorders. It features tympanometry, acoustic reflex and<br>air conduction audiometry. |
| Intended operator | The AT235 tympanometer is intended to be used by an audiologist,<br>hearing healthcare professional, or trained technician. |
| Technological<br>Characteristics | The instrument is software controlled. The software controls the<br>probe (tone and pressure) stimuli, measures the result and<br>presents the result on a built in display. All functions are set and<br>interpreted by the operator (There are no interpretations of results<br>in the device). The technological characteristics are substantially<br>equivalent with predicate device. All technological characteristics<br>are in compliance with the consensus standard ANSI S3.39 for<br>auditory impedance testers |
| Nonclinical tests summary | Following the design control procedure the design verification and<br>validation were performed according to current standards for<br>medical device safety and EMC and performance of impedance |

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tester. The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device.

Clinical tests None applicable The AT235 as a modification to the predicate device (the previous Conclusion cleared revision of AT235) uses the same or identical technology and has the same intended use as the predicate device. We trust that the verification and validation activities show substantial equivalence with the predicate device and that the modified AT235 is as safe and effective as the predicate device for its claimed purpose.