(13 days)
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.
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.
The provided document outlines the acceptance criteria and a study demonstrating the SpeechLink 100 type 1053 device's performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Agreement with Predicate Device (Audioscan Verifit VF-1) | "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." |
| Compliance with IEC 61669 (2001-01) tolerances | "any observable differences between the peak curves are smaller than the tolerances regulated by the standard IEC 61669 (2001-01)" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a specific numerical sample size for the test set. It refers to "Speech mapping recordings" being measured, implying multiple recordings were taken.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The study compares the device's measurements against a predicate device and a technical standard and does not involve human expert interpretation of results to establish ground truth in the traditional sense of medical image analysis or diagnosis.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, the comparison is against a predicate device's measurements and technical standard tolerances, not against adjudicated expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study compares the device against another device and a technical standard, not human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, a standalone performance assessment was conducted. The study directly compares the measurements from the SpeechLink 100 with those from the Audioscan Verifit VF-1, and assesses its compliance with a technical standard. This is an evaluation of the device's (or its underlying algorithm's) performance in generating measurements without human intervention in the measurement process itself.
7. Type of Ground Truth Used:
- The ground truth in this context is established by:
- The measurements obtained from the predicate device (Audioscan Verifit VF-1).
- The tolerances defined by the IEC 61669 (2001-01) Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids standard.
8. Sample Size for the Training Set:
- Not applicable. The provided document details a performance study comparing the device to a predicate and a standard, not a machine learning model's training process.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. The provided document details a performance study comparing the device to a predicate and a standard, not a machine learning model's training process.
{0}------------------------------------------------
MAY 3 2006
510(k) Summary of Safety and Effectiveness
Submitter
| Name and address: | GN Otometrics A/SDybendalsvaenget 2DK-2630 TaastrupDenmark |
|---|---|
| Phone: | +45 7211 1555 |
| Fax: | +45 7211 1548 |
| 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.
7 of 45
{1}------------------------------------------------
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, PCbased 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 1997real-ear systemrequirements whereapplicable | Meets ANSI S3.46 1997real-ear system requirements |
| Frequency range | 125 - 8,000 Hz generationand measurement | 200 - 8,000 Hz generationand measurement |
| Stimulus types (levels, dBSPL) | Pink noise (40 - 90) | Pink noise (40 - 90) |
| Digitized conversationsmale/female (55 - 75) | Digitized individual malespeech (55 - 75) | |
| Digitized conversationsfemale/male (55 - 75) | Digitized individual femalespeech (55 - 75) | |
| Digitized conversationsmale/female/child (55 - 75) | Digitized individual childspeech (55-75) | |
| International Collegium ofRehabilitative Audiology(ICRA) speech (55 - 75) | International Collegium ofRehabilitative Audiology(ICRA) speech (55 - 75) |
8 of 45
{2}------------------------------------------------
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
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are arranged on a single line. The background of the image is white.
Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.
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.
{4}------------------------------------------------
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 (301) 827-8910. 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 (800) 638-2041 or (301) 443-6597 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
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
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
Page 1 of
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
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.(b)
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.