AURICAL HIT

K122028 · Gn Otometrics · ETW · Oct 23, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K122028
• Device Name: AURICAL HIT
• Applicant: Gn Otometrics
• Product Code: ETW · Ear, Nose, Throat
• Decision Date: Oct 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3310
• Device Class: Class 2

Indications for Use

The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

Device Story

Aurical HIT Type 1082 is a hearing instrument test system; connects via USB to PC running OTOsuite software. Device features a test chamber with snap-on couplers for hearing instrument positioning; includes automatic battery pill recognition and reference microphone for reliable positioning. System presents acoustic sounds and magnetic field stimuli to assess audio processing and telecoil functionality. Used by audiologists and technicians in clinical settings to perform testing per ANSI/IEC protocols; also supports Probe Microphone Measurements (PMM) for pre-programming/pre-fitting without client presence. Output displayed via OTOsuite software; enables consistent evaluation of hearing instruments regardless of manufacturer. Benefits include standardized performance verification and efficient pre-fitting workflows.

Clinical Evidence

Bench testing only. Device tested against ANSI S3.22: 2003 and IEC 60118-7: 2005 standards. Electrical safety verified per IEC 61010-1; EMC verified per IEC 61326-1. Software validation and risk analysis performed.

Technological Characteristics

Hearing aid calibrator/analysis system. USB 2.0 connectivity; max power 2.5 W. Includes test chamber, snap-on couplers, and reference microphone. Software-controlled via OTOsuite. Standards: ANSI S3.22: 2003, IEC 60118-7: 2005, IEC 61010-1 (Safety), IEC 61326-1 (EMC).

Indications for Use

Indicated for use by audiologists, technicians, and professionals to assess audio processing and telecoil functionality of hearing instruments via acoustic and magnetic stimuli.

Regulatory Classification

Identification

A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

Special Controls

*Classification.* Class II (special controls). The device 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

• PRIMUS HEARING INSTRUMENT TEST UNIT (K113831)

Submission Summary (Full Text)

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510(K) Summary, 510(k) K122028 Submitter: GN Otometrics A/S Hoerskaetten 9 Taastrup, DENMARK DK-2630 Registration number: 9612197 C/O GN Otometrics North America 50 Commerce Dr Ste 180 Schaumburg, IL 60173 (US) Phone: [phone] (US) Fax: [phone] Contact: Dan Sansonetti, Manager of Research and Development Date Prepared: October 16, 2012

**OCT**
2 3
2012

- Identification of the Device: 1. Proprietary-Trade Name: Aurical HIT Type 1082 Classification Name: Calibrator, hearing aid / earphone and analysis systems, Class II Common/Usual Name: Hearing aid calibrator
- 2. Product code: ETW
- Equivalent legally marketed devices: 510(K) Number K113831 PRIMUS HEARING 3. INSTRUMENT TEST UNIT, AUDITDATA A/S.
- Description of the Device: AURICAL HIT is designed for Hearing Instrument Testing and 4. Coupler-Based Fitting. AURICAL HIT connects via USB to a computer running the OTOsuite software. With the OTOsuite HIT Module one can perform traditional hearing instrument testing according to either the ANSI or IEC test protocols, and obtain a consistent picture of every hearing instrument, regardless of manufacturer or type. With the OTOsuite PMM Module one can perform Probe Microphone Measurements in a coupler for pre-programming and pre-fitting hearing instruments without the client being present. It is easy to position hearing instruments on snap-on couplers inside the AURICAL HIT test chamber and it is easy to access the hearing instruments in the test chamber during test without disturbing the test setup. The battery pill types are recognized automatically, and the reference microphone ensures reliable positioning in the test chamber.
- న. Indications for Use (intended use): The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in ' conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.
- Safety and Effectiveness, comparison to predicate device. This device has the same indications 6. for use as the predicate device and employs similar technology to accomplish the same tasks.
- 7. Description of Testing: Testing consisted of non-clinical performance testing of the device against the applicable parameters specified in the following standards: ANSI S3.22: 2003, and IEC 60118-7:2005 The device passed UL Electrical Safety (IEC 61010-1) testing and EMC (IEC 61326-1) testing. Software validation and risk analysis was performed.

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## Substantial Equivalence Chart 8.

1

. . ・・

| | Characteristic | Auditdata Primus K113831 | Aurical HIT Type 1082 |
|--|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use: | Hearing Aid Testing | Hearing Aid Testing |
| | Hearing-aid test-box characteristics: | | |
| | C/Tests | OSPL90 | OSPL90 & HFA-OSPL90 |
| | | Full on gain | Full on gain |
| | | Input/Output | Input/Output |
| | | Attack/Recovery time | Attack/Recovery time |
| | | Reference test gain | Reference test gain |
| | | Frequency response | Frequency response |
| | | Equivalent input noise | Equivalent input noise |
| | | Harmonic distortion | Harmonic distortion |
| | | Battery current drain | Battery current drain |
| | | TeleCoil | TeleCoil |
| | Test Level Range: | 50 - 90 dB SPL | 40 - 100 dB SPL |
| | Freq. Range | 125 Hz - 8 kHz | 125 - 10,000 Hz |
| | Standards met for Hearing | ANSI S3.22 | ANSI S3.22: 2003 |
| | Instrument Testing | IEC 60118-7 | IEC 60118-7: 2005 |
| | Electrical Safety | IEC 60601-1, Class 1, Type B | IEC 61010-1 |
| | EMC | IEC 60601-2 | IEC 61326-1 |
| | Power supply | USB, and external power supply<br>for elevated outputs | USB Max. 2.5 W |
| | Communication port | USB 2 | USB 2.0 |
| | PC minimum requirements | CPU Minimum 1.4 GHz processor<br>with 512 MB (1 GB recommended)<br>system RAM<br>Harddisk space 1 GB free harddisk<br>space for Primus<br>Operating system Windows XP<br>Professional SP2 (32-bit), Windows<br>Vista (32-bit) including: Vista Home<br>Basic, Vista Home Premium, Vista<br>Business, Vista Enterprise and Vista<br>Ultimate, Windows 7 (32-bit)<br>including Windows 7<br>Home Premium, Windows 7<br>Professional and Windows 7<br>Ultimate Graphics card 1024 x 768.<br>XVGA Connections CD drive and<br>USB 2.0 connection required | 1.5 GHz processor or higher (2 GHz<br>recommended) • 512 MB RAM (1 GB<br>recommended) for Windows XP, or 1<br>GB (1.5 GB recommended) for<br>Windows Vista and Windows 7 • 2.5<br>GB free disk space for installation of the<br>OTOsuite software. Additional disk<br>space is needed for installation of<br>prerequisites • Windows® XP (32 bit)<br>with SP3 or higher, or Windows Vista<br>(32 bit) with SP2, or Windows 7 (32 or<br>64 bit) • USB port for connecting<br>accessories, v. 1.1, or 2.0 • DVD or CD-<br>ROM drive • 32 bit color display,<br>1024x768 screen resolution • 32 MB<br>graphic memory • Windows-compatible<br>sound card • Supports NOAH 3.5,<br>NOAH 3.5 for ENTs, or higher, for<br>NOAH mode operation. |

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## K122028

| Characteristic | Auditdata Primus K113831 | Aurical HIT Type 1082 |
|----------------|---------------------------------|------------------------------|
| Photo | Image: Auditdata Primus K113831 | Image: Aurical HIT Type 1082 |

- 9. Conclusion: The Aurical HIT Type 1082 meets applicable standards for hearing instrument testers: ANSI S3.22: 2003 and IEC 60118-7: 2005. Per the bench performance testing, software testing, and safety testing, we conclude that the Aurical HIT Type 1082 is as safe and effective as the predicate device, and has essentially the same indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

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

GN Otometrics A/S c/o Daniel Kamm. P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Ct. Naples, FL 34114

Re: K122028

Trade/Device Name: Aurical HIT Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing aid calibrator and analysis system Regulatory Class: Class II Product Code: ETW Dated: September 11, 2012 Received: September 21, 2012

Dear Mr. Kamm:

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.

OCT 2 3 2012

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Page 2 - Daniel Kamm. P.E.

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Edw. K. Underwood

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

Enclosure

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K122028

## Indications for Use

510(k) Number (if known): K122028

Device Name: Aurical HIT Type 1082

Indications For Use:

The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

Prescription Use X 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vassil Raich

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K122028

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