SPEECHLINK 100 TYPE 1053

K061104 · Gn Otometrics A/S · ETW · May 3, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K061104
• Device Name: SPEECHLINK 100 TYPE 1053
• Applicant: Gn Otometrics A/S
• Product Code: ETW · Ear, Nose, Throat
• Decision Date: May 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3310
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.

Device Story

SpeechLink 100 is a PC-based hearing aid calibrator and analysis system. It consists of a body-worn neckset with two probe microphones, a charger, and PC-based software. The neckset communicates with the PC via a wireless Bluetooth link. The device generates various stimuli, including pink noise, digitized speech (male, female, child), and ICRA speech signals (55-75 dB SPL). It measures the electroacoustic frequency response and sound intensity of hearing aids. The system is used by audiologists or hearing professionals to perform spectral analysis and fitting of hearing instruments. By comparing the hearing aid output against standard electroacoustic requirements, the device assists clinicians in verifying hearing aid performance, ensuring accurate fitting, and optimizing patient benefit through precise sound amplification adjustments.

Clinical Evidence

Bench testing only. Comparative performance study conducted between SpeechLink 100 and Audioscan Verifit VF-1. Probe microphones were positioned to measure frequency response in the same sound field. Results showed high agreement between systems, with peak curve differences smaller than tolerances regulated by IEC 61669 (2001-01).

Technological Characteristics

Body-worn main unit; PC-based system. Bluetooth wireless interface. Battery-powered. Frequency range: 125-8,000 Hz. Stimuli: Pink noise, digitized speech (male/female/child), ICRA speech. Meets ANSI S3.46 1997 real-ear system requirements. Safety compliance: IEC 60601-1, EN 60601-1-1, EN 60601-1-2. Quality standards: ISO 9001:2000, ISO 13485:2003.

Indications for Use

Indicated for use as an electronic reference device to calibrate and assess electroacoustic frequency and sound intensity characteristics of hearing aids. Intended for prescription use.

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

• Audioscan Verifit Model VF-1 (K012306)
• Otoflex 100 Type 1012 (K033645)

Submission Summary (Full Text)

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### MAY 3 2006

### 510(k) Summary of Safety and Effectiveness

#### Submitter

| Name and address: | GN Otometrics A/S<br>Dybendalsvaenget 2<br>DK-2630 Taastrup<br>Denmark |
|-------------------|------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact person: | Per Pape Thomsen |

Summary prepared: February 15, 2006

#### Device name

| Common/Usual name: | Audio Fitting System |
|-------------------------|--------------------------------------------|
| Trade/Proprietary name: | SpeechLink 100 type 1053 |
| Classification name: | Hearing aid calibrator and analysis system |

### Predicate devices

SpeechLink is similar to the product Audioscan Verifit Model VF-1 (K012306) but differs in three ways: body worn operation powered by battery, number of tests available and wireless computer interface.

Wireless computer interface and battery operation is currently performed by Otoflex 100 Type 1012 (K033645).

### Description

The SpeechLink is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from self-contained software modules installed on a common software platform. The following applications are available: Audio fitting system and Simulator system.

The fitting system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link, i.e. no physical connection to the PC.

The simulator consists of software for installation on a PC and hardware for connection to a PC.

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### Indications for Use

The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.

### Technological Characteristics

| Device Specifications | SpeechLink 100 | Audioscan Verifit |
|------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Safety compliance | IEC 60601-1 | IEC 60601-1 |
| Construction type | Body worn main unit, PC<br>based system | Desktop system |
| Power source | Battery | Mains |
| Computer interface | Bluetooth radio link | RS232 cable connection |
| Supporting software | NOAH database SW | NOAH database SW |
| ANSI real ear requirements | Meets ANSI S3.46 1997<br>real-ear system<br>requirements where<br>applicable | Meets ANSI S3.46 1997<br>real-ear system requirements |
| Frequency range | 125 - 8,000 Hz generation<br>and measurement | 200 - 8,000 Hz generation<br>and measurement |
| Stimulus types (levels, dB<br>SPL) | Pink noise (40 - 90) | Pink noise (40 - 90) |
| | Digitized conversations<br>male/female (55 - 75) | Digitized individual male<br>speech (55 - 75) |
| | Digitized conversations<br>female/male (55 - 75) | Digitized individual female<br>speech (55 - 75) |
| | Digitized conversations<br>male/female/child (55 - 75) | Digitized individual child<br>speech (55-75) |
| | International Collegium of<br>Rehabilitative Audiology<br>(ICRA) speech (55 - 75) | International Collegium of<br>Rehabilitative Audiology<br>(ICRA) speech (55 - 75) |

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### Performance testing

Speech mapping recordings were measured simultaneously using the GN Otometrics SpeechLink 100 and the Audioscan Verifit VF-1. The probe microphone tubes were carefully positioned to measure the frequency response in the exact same location in the sound field.

The results show that there is high agreement between the measurements from the systems and that any observable differences between the peak curves are smaller than the tolerances regulated by the standard IEC 61669 (2001-01) Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids.

It is therefore concluded that the two systems are equally accurate.

### Safety

SpeechLink is designed to provide safety to the patient as well as the user and complies with:

- EN 60601-1:1990, UL 60601-1:2003, CAN/CSA-C22.2 NO 601.1-90:1990 . Medical Electrical Equipment. Part 1: General requirements for safety
- EN 60601-1-1:2001: Medical Electrical Equipment. Part 1: Generel . requirements for safety. 1. Collateral standard: Safety requirements for medical electrical systems
- EN 60601-1-2:2001 Medical Electrical Equipment. Part 1-2: Generel . requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests

SpeechLink is designed, developed and manufactured according to:

- . ISO 9001:2000 Quality Management Systems - Requirements
- ISO13485:2003 Quality management systems Requirements for regulatory . purposes

#### Effectiveness

The SpeechLink is a hearing aid calibrator and analysis system for hearing instrument fitting using spectral analysis. SpeechLink is of a technology type that is available and accepted in the market

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 2006

GN OTOMETRICS A/S c/o Mr. Daniel W. Lehtonen Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg OH 44087

Re: K061104

Trade/Device Name: SpeechLink100 type 1053 Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing aid calibrator and analysis system Regulatory Class: Class II Product Code: ETW Dated: April 19, 2006 Received: April 21, 2006

Dear Mr. Lehtonen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); 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.

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## Page 2 - Mr. Daniel W. Lehtonen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our.labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

M.B. Eychhaus M.D.

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):

K061104

Device Name:

SpeechLink 100 type 1053

Indications For Use:

The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kama A Boker
***_***_, (Division Sign, or)

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K-061104

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