ARTICULATE FITTING SYSTEM

K973320 · Decibel Instruments, Inc. · EWO · Nov 25, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973320
• Device Name: ARTICULATE FITTING SYSTEM
• Applicant: Decibel Instruments, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Nov 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™ Audiometer 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.

Device Story

Articulate Fitting System comprises ProDigit 2000 audiometer, IntraCanal Probe (ICP) transducer, ICP interface, and Articulate Fitting software. System integrates with HI-PRO hearing aid programmer. Used by audiologists/professionals in clinical settings to perform audiometric testing, real ear measurements, and hearing aid programming. Input: acoustic stimuli (pure tones, speech, masking signals) delivered via ICP. Processing: software utilizes automated fitting algorithms and visual tools to calculate and apply fitting parameters to programmable hearing devices. Output: diagnostic hearing data, real ear measurement results, and programmed hearing aid settings. Benefits: enables precise, individualized hearing instrument fitting and diagnostic evaluation of otologic disorders.

Clinical Evidence

Bench testing only. Evaluated electroacoustic performance of the IntraCanal Probe (ICP), including frequency response, linearity, and maximum undistorted acoustic output versus constant voltage input. Results demonstrated a smooth, well-defined acoustic frequency response within specified limits and linear response below maximum output levels.

Technological Characteristics

Computer-based audiometer; IntraCanal Probe (ICP) transducer; HI-PRO universal hearing aid programmer interface. Features include real ear measurement, dB SPL audiometry, and automated fitting algorithms. System is networked/integrated with external hearing aid programming hardware.

Indications for Use

Indicated for use by trained audiologists or audiometric professionals to conduct diagnostic hearing evaluations, assist in the diagnosis of otologic disorders, and fit/program Articulate Hearing Devices in patients requiring hearing assessment or amplification.

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

• Decibel Instruments ProDigit 2000™ Personal Digital Audiometer (K940999)
• Madsen Electronics RH2000 Real Ear Measurement System (K945199)

Submission Summary (Full Text)

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.k973320

## SECTION 2 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

NOV 2 5 1997

Submitter's Name: Decibel Instruments, Inc. 3857 Breakwater Ave. Hayward, CA 94545 USA Telephone: [phone] Contact Person: Adnan Shennib, Chief Technical Officer

Date of Summary: August 29, 1997

Device Name: Articulate Fitting System™

Device Classification: Audiometer (77 EWO); 21 CFR § 874.1050

Legally Marketed Predicate Devices: The legally marketed predicate devices are:

- The Decibel Instruments ProDigit 2000™ Personal Digital Audiometer (K940999), . determined to be substantially equivalent to a legally marketed (preAmendment) device on April 22, 1994, and
- The Madsen Electronics RH2000 Real Ear Measurement System (K945199), determined ● to be substantially equivalent to a legally marketed (preAmendment) device on April 11, 1995.

Device Description: The Articulate Fitting System™ is used with the Decibel Instruments ProDigit 2000™ Personal Digital Audiometer for audiometric testing, real ear measurements, and fitting and programming the commercially available Decibel Instruments Articulate Hearing Devices. The System has four main components:

- The legally marketed Decibel Instruments ProDigit 2000™ Personal Digital Audiometer, a . computer-based audiometry system;
- The Decibel Instruments IntraCanal Probe™ (ICP), a transducer placed in the ear canal . for audiometric testing;
- The Decibel Instruments IntraCanal Probe™ Interface, which provides the communication . link between the ICP and the ProDigit 2000™ Audiometer and allows real ear measurements; and
- The commercially available HI-PRO hearing aid programmer with the Articulate Fitting . software utilizes automated fitting algorithms and visual tools to program the Articulate Hearing Devices following audiometric evaluation.

Intended Use: The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™

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Audiometer 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.

## Descriptive Summary Of Technological Characteristics And Those Of Predicate

Devices: The ProDigit 2000™ Personal Digital Audiometer is a computer-based instrument used to evaluate human hearing function and to assist in the diagnosis of possible otologic disorders. The audiometer is typically used by trained and qualified audiologists or other audiometric professionals. The instrument generates audio stimuli having various acoustic properties in order to elicit responses from the test subject; the responses are used to assess hearing function. Typical stimuli consist of pure tones, speech, and masking signals which are delivered to the ear via acoustic couplers, or transducers.

The Articulate Fitting System™ is indicated for use with the ProDigit 2000™ Personal Digital Audiometer to conduct audiometric evaluation, and to fit and program Articulate Hearing Devices. In addition to the features of the ProDigit 2000™ Audiometer, the Articulate Fitting System provides programming capabilities (including auto-fit calculations) for Decibel Instruments Articulate programmable hearing instruments when used with the commercially available HI-PRO Universal Hearing Aid programmer. The Articulate Fitting System also provides individualized fitting capabilities and subjective testing for fit of all Decibel Instruments Articulate hearing instruments, both non-programmable and programmable models. Other features include real ear measurements and dB SPL audiometry using the IntraCanal Probe (ICP).

The Madsen Electronics RH2000 Real Ear Measurement System (Aurical) is a computerbased instrument used to evaluate human hearing function and to assist in the diagnosis of possible otologic disorders. In addition to standard audiometric capabilities, the Aurical provides programming capabilities for programmable hearing instruments when used with the commercially available HI-PRO Universal Hearing Aid programmer, as well as subjective testing for fit of hearing instruments. Other capabilities include real ear measurements, noise signals testing, auditory area mapping and hearing instrument evaluation.

Performance Data: Testing was conducted by Decibel Instruments. Inc. to evaluate the electroacoustic performance of the IntraCanal Probe (ICP). The frequency response, linearity. and maximum undistorted acoustic output versus constant voltage input and frequency were measured. The ICP demonstrated a smooth, well-defined acoustic frequency response within specified limits, and the response was linear below the maximum undistorted acoustic output levels. When used in accordance with the labeling, the ICP can be expected to deliver accurate acoustic stimuli for performing audiometric testing.

Conclusion: The information and data provided in this 510(k) Notification establish that the Articulate Fitting System™ used with the ProDigit 2000™ Personal Digital Audiometer is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a stylized eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa S. Jones, R.A.C. Regulatory Affairs Consultant Decibel Instruments, Inc. c/o Devices for the Future, LLC 9223 Ilona Lane Houston, TX 77025-4218

Re: K973320 Articulate Fitting System (Audiometer) Dated: August 29, 1997 Received: September 3, 1997 Regulatory Class: II 21 CFR 874.1050/Procode: 77 EWO

NOV 25 1997

Dear Ms. Jones:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 marked 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 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.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Liao Yu

Lillian Yin, Ph.D. 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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510(k) Number (if known):_ 长97 33 ZC

Device Name: ARTICULATE HEARING SysTEM

Indications For Use:

Intended Use: The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™

Audiometer 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel le Seigman

Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number

Prescription Use_ V (Per 21 CFR 801.109)

·

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)