DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS

K984547 · Resound Corp. · EWO · Mar 19, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K984547
• Device Name: DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
• Applicant: Resound Corp.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Mar 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource II fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals. The purpose of the ReSound LGOB test is to evaluate a patient's suprathreshold hearing at specific frequencies. This is the range of hearing above a person's threshold level but below their uncomfortable loudness level. The results of this test are used by the ReSource software to calculate hearing instrument fittings that are better tailored to the patient's residual dynamic range of hearing. The LGOB test procedure requires the patient to evaluate narrow bands of noise signals generated directly the Digital-to-Analog converter within the hearing device. The noise signal is Too Loud, Very Loud, Loud, Comfortable, Soft, Very Soft or Inaudible by entering their response with the hand held Personal Selector, which is the identical recording device used with the original P3 system from ReSound. The new LGOB application uses the patient's own digital hearing device or a stock "Digital Master" device to produce the sound stimulus directly from the Digital to Analog converter (DAC) within the hearing aid's Digital Signal Processor. No insert earphones are required. Either BTE or Custom In-The-Ear devices can be used to perform the LGOB loudness scaling measurements. The test protocol is initiated and controlled by connecting a Digital hearing device to a personal computer and using proprietary fitting software (ReSource II). When the fitting computer is disconnected, the hearing instrument functions normally. Results from the test are used to provide fitting recommendations and initial device amplification parameter settings for the Digital 5000 and other programmable ReSound hearing devices.

Device Story

System uses ReSound Digital 5000 series hearing devices to perform Loudness Growth in Octave Bands (LGOB) testing; replaces traditional insert earphones with direct sound generation via hearing aid's internal Digital-to-Analog Converter (DAC). Hearing professional connects device to PC running ReSource II software; software instructs DAC to produce 1/2 octave bands of noise at varying frequencies/amplitudes. Patient uses handheld 7-button Personal Selector to rate perceived loudness (Too Loud to Inaudible). Software collects/stores data; calculates target response curves/amplification settings based on LGOB and audiometric threshold data. Facilitates precise fitting of hearing aid to patient's residual dynamic range. Used in clinical settings by hearing health professionals; device functions as standard hearing aid when disconnected from PC.

Clinical Evidence

Bench testing only. System relies on established LGOB loudness scaling methodology (Allen et al., 1988/1990). No clinical trial data presented; equivalence established through technical comparison of stimulus generation and software-based fitting workflow.

Technological Characteristics

System comprises PC software and Digital 5000 series hearing aids. Hearing aids feature custom digital signal processor (DSP) with two ADCs and one DAC. Connectivity via standard CS45 cable to PC. Software-controlled stimulus generation. Complies with ANSI S3.6-1996, ANSI S1.6-1984, and ANSI S3.22-1996. Software developed per IEEE 1012-1986.

Indications for Use

Indicated for hearing-impaired patients requiring audiometric assessment of suprathreshold hearing to improve hearing aid fitting accuracy. Intended for use by qualified hearing healthcare professionals.

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device 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.

Predicate Devices

• ReSound® Portable Prescriptive Programming (P3) System (K912669)

Reference Devices

• ReSound ReSource II software (K945750)
• Noah operating system (K942749)

Submission Summary (Full Text)

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3/19/99

Image /page/0/Picture/1 description: The image shows the logo for ReSound Hearing Health Care. The word "RESOUND" is in large, bold, sans-serif font. Below it, the words "Hearing Health Care" are in a smaller, sans-serif font.

K984547

510(k) Premarket Notification - LGOB Using Digital Hearing Devices

### EXHIBIT E

## 510(k) Summary of Safety and Effectiveness

[As required by 807.92(c)]

Submitter:

ReSound Corporation 220 Saginaw Drive, Seaport Centre, Redwood City, CA 94063 Tel: [phone] Fax: [phone]

Contact Person:

December 20, 1998 Date:

Common/Usual Name: Audiometer; Digital Master Hearing Aid

Gary Roesel

LGOB Test using ReSound® Digital 5000 Series Hearing Devices Proprietary Name:

Panel 77, Procode ESD Classification CFR Part 874 – Ear, Nose, and Throat Devices Diagnostic Devices - 874.1050 Audiometer Subpart B -Prosthetic Devices - 874.3330 Master Hearing Aid Subpart D --

Establishment Registration: 2939186

#### References and Performance Standards:

Applicable sections of ANSI S3.6 - 1996, "Specification for Audiometers."

Applicable sections of ANSI S1.6-1984 (R 1990), "Preferred Frequencies, Frequency Levels and Band Numbers for Acoustical Measurements."

Applicable sections of ANSI S3.22-1996, "Specification of Hearing Aid Characteristics."

Software development and validation according to IEEE 1012-1986 and the FDA Guidelines for Computer Controlled Medical Devices.

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J. B. Allen. J. L. Hall, and P. S. Jeng. "Loudness growth in 1/2-octave bands (LGOB) - A procedure for the assessment of loudness", Journal of the Acoustical Society of America - 1988 (2), 1990, pp. 745-753.

Using the Digital 5000 series of hearing devices to produce sound Substantial Equivalence: stimuli and perform LGOB loudness scaling measurements is substantially equivalent to other currently marketed audiometric diagnostic testing equipment, and is almost identical to that marketed as the ReSound® Portable Prescriptive Programming (P3) System (K912669).

ReSound's Digital 5000 series hearing devices are built using a custom Description: software programmable digital signal processor. The DSP includes two analog to digital converters (ADC) at the input stage and one digital to analog converter (DAC) at the output stage. Using a personal computer (PC) connected to the hearing device via standard CS45 cable, numerous signal processing and amplification parameters may be adjusted to help compensate for impaired hearing. In addition, proprietary software used only by hearing health care professionals can instruct the output DAC to produce specific sounds. These sound stimuli, when delivered at different amplitudes and frequencies, can be used for loudness scaling measurements helpful in fitting the hearing device more precisely to the patient's residual hearing dynamic range.

The "Loudness Growth in Octave Bands" (LGOB) loudness scaling test Intended Use: is intended to be used by hearing health care professionals as a supplemental audiometric measurement'. The LGOB test is intended to simplify and improve the accuracy of the fitting process for ReSound Digital or Analog hearing devices. Specifically, the test uses the Digital 5000 hearing device and proprietary software to directly produce 1/2 octave bands of noise presented at varying output levels and centered at varying frequencies. The hearing device wearer indicates their perceived loudness for each stimulus.

The new Loudness Growth in Octave Bands (LGOB) test application of Predicate Device: ReSound's Digital 5000 series hearing devices is substantially equivalent to the LGOB test developed by ReSound and provided with the original ReSound® P3 System cleared under 510(k) K912669, September 16, 1991. In the predicate device, the LGOB sound stimulus was generated by the Personal Prescriptive Programmer hardware and delivered via a set of insert earphones.

> The new LGOB application uses the patient's own digital hearing device or a stock "Digital Master" device to produce the sound stimulus

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directly from the Digital to Analog converter within the hearing aid's Digital Signal Processor. No insert earphones are required. Either BTE or Custom In The Ear devices can be used to perform the LGOB loudness scaling measurements. The test protocol is initiated and controlled by connecting a ReSound Corporation Digital hearing device to a personal computer and using proprietary fitting software (ReSound ReSource II). The patient's subjective loudness perception of each stimulus is recorded using the handheld Personal Selector, which is the identical recording device used with the original P3 system. When the fitting computer system is disconnected, the hearing instrument functions normally.

#### Summary:

The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. Using the Digital 5000 series of hearing devices to perform LGOB measurements is substantially equivalent to the LGOB procedure pioneered by ReSound and marketed with the ReSound Portable Prescriptive Programming (P3) System (K912669). The software which controls the system is incorporated into ReSound® ReSource II software (K945750) that runs as a standalone application or can be integrated under the Noah operating system (K942749).

The LGOB test equipment is comprised of proprietary PC software and a ReSound Digital 5000 series hearing device. Similar to the Loudness Growth in Octave Bands (LGOB) test provided with the original ReSound® P3 System, this new hearing device fitting method is designed to subjectively measure loudness growth in hearingimpaired subjects using the subject's own hearing aid, instead of using insert phones. The test is to be performed only by qualified hearing healthcare professionals. When the hearing aids are disconnected from the fitting computer, they function normally.

Substantial equivalence of this analysis system to currently marketed real ear systems mentioned above is based on the following:

- This system produces speech shaped noise stimuli delivered directly to the (1) patient's ear canal;
- (2) Measures the perceived intensity of the signals via a hand held 7-button Personal Selector, and;
- Displays the measurement results on the PC screen. (3)

⁴ J. B. Allen, J. L. Hall, and P. S. Jeng, "Loudness growth in ½-octave bands (LGOB) - A procedure for the assessment of loudness", Journal of the Acoustical Society of America - 1988 (2), 1990, pp. 745-753.

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The new LGOB test procedure requires the patient to evaluate ½ octave bands of pseudo-random noise signals generated directly by the Digital-to-Analog Converter (DAC) within the Digital hearing device. The patient indicates if they perceive the noise signal to be: Too Loud, Very Loud, Loud, Comfortable, Soft, Very Soft or Inaudible by entering their response with the hand held Personal Selector.

The proprietary software collects, labels and stores the resulting loudness sensitivity data. The fitting target and subsequent hearing aid amplification settings for the Digital 5000 (or other programmable ReSound hearing devices) are derived from the LGOB suprathreshold data and supplied audiometric threshold data. Any and all settings for the device which are chosen by the software can be easily and directly changed by the hearing device fitting professional, as with all other ReSound digital or analog hearing aids.

The new ReSound LGOB incorporates the patient's subjective response data along with the patient's audiometric data (entered separately) in the calculation of target response curves for the fitting of ReSound hearing devices. The intended use, method and theory of test operation, fundamental testing protocol, application and calibration of test results are equivalent to the predicate ReSound P system.

The use of the ReSound® LGOB loudness scaling system with the Digital 5000 series hearing devices does not significantly affect the safety or effectiveness of the currently marketed ReSound Digital 5000 family of hearing devices or the currently marketed ReSound ReSource II fitting software.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

Gary W. Roesel Director of Worldwide Technical Services, Regulatory Affairs ReSound Corporation 220 Saginaw Drive Seaport Centre Redwood City, CA

Re:

K984547 LGOB Test using ReSound™ Digital 5000 Series Hearing Devices Dated: December 20, 1998 Received: December 22, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO 21 CFR 874.3330/Procode: 77 KHL

Dear Mr. Roesel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

BART Daniel S. Stulberg, M.D.

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for ReSound Hearing Health Care. The word "RESOUND" is in a large, bold, sans-serif font. Below the word "RESOUND" is the phrase "Hearing Health Care" in a smaller, sans-serif font. The logo is black and white.

510(k) Premarket Notification - LGOB Using Digital Hearing Devices

### EXHIBIT B

# INDICATION FOR USE STATEMENT

510(k) Number (if known):

ReSound LGOB Procedure using Digital 5000 series hearing devices Device Name:

Indications for Use:

The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource II fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals.

The purpose of the ReSound LGOB test is to evaluate a patient's suprathreshold hearing at specific frequencies. This is the range of hearing above a person's threshold level but below their uncomfortable loudness level. The results of this test are used by the ReSource software to calculate hearing instrument fittings that are better tailored to the patient's residual dynamic range of hearing. The LGOB test procedure requires the patient to evaluate narrow bands of noise signals generated directly the Digital-to-Analog converter within the hearing device. The noise signal is Too Loud, Very Loud, Loud, Comfortable, Soft, Very Soft or Inaudible by entering their response with the hand held Personal Selector, which is the identical recording device used with the original P3 system from ReSound.

The new LGOB application uses the patient's own digital hearing device or a stock "Digital Master" device to produce the sound stimulus directly from the Digital to Analog converter (DAC) within the hearing aid's Digital Signal Processor. No insert earphones are required. Either BTE or Custom In-The-Ear devices can be used to perform the LGOB loudness scaling measurements. The test protocol is initiated and controlled by connecting a Digital hearing device to a personal computer and using proprietary fitting software (ReSource II). When the fitting computer is disconnected, the hearing instrument functions normally.

Results from the test are used to provide fitting recommendations and initial device amplification parameter settings for the Digital 5000 and other programmable ReSound hearing devices.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Page 1

(Division Sign-Off)ress
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
K981547

510(k) Submission: ReSound digital LGOB