SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL

K984518 · Sonic Innovations, Inc. · ESD · Mar 12, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K984518
• Device Name: SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
• Applicant: Sonic Innovations, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This air conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses of mild to moderate degree.

Device Story

Completely-in-the-canal (CIC) hearing aid; utilizes digital signal processing (DSP) to amplify sound pressure waves. Input: ambient sound; Output: amplified acoustic signal. Features full dynamic range multiband compression (multiplicative DSP) allowing independent gain/compression adjustment across frequency bands (250-8000 Hz). Device is programmable via PC-based software (HI-Pro/Noah). Used by patients with mild-to-moderate hearing loss; fitted by hearing aid dispensers. Soft shell component is biocompatible, removable, and replaceable. Benefits patient by compensating for hearing impairment through customized amplification.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and compliance with ANSI S3.22 1987 standards.

Technological Characteristics

CIC hearing aid; biocompatible soft shell; zinc-air size 10 battery; digital signal processing; multiband compression; programmable via PC interface; ANSI S3.22 1987 compliant.

Indications for Use

Indicated for individuals with slight, mild, or moderate hearing impairment, including high frequency precipitously sloping, gradually sloping, reverse slope, or flat configurations, and those with low tolerance for loud sounds.

Regulatory Classification

Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

Predicate Devices

• SONIC innovations CIC DSP hearing aid (K984518)
• Decibel Instruments Articular (inTune) Hearing Aids (K964603)
• Hearing Components Ad-Hear Comply Disposable Earmolds (K915794)

Submission Summary (Full Text)

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510(k) Premarket Notification
Sonic Innovations CIC DSP Hearing Aid

K984518

SONIC innovations

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

for the

SONIC INNOVATIONS® COMPLETELY-IN-THE-CANAL (CIC) DSP HEARING AID

## Prepared: December 10, 1998

Submitted by: Jeannette Seloover Johnson, Ph.D. Vice President, Research and Planning SONIC innovations Inc. 5330 South 900 East, Suite 240 Salt Lake City, Utah 84117-7261 Telephone [phone] Fax [phone]

| Classification Name: | Hearing Aid - Air Conduction |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Hearing Aid |
| Proprietary Name: | SONIC innovations® Completely-in-the-Canal DSP<br>Hearing Aid with Soft Shell |
| Device Type: | Completely-in-the-Canal (CIC) Hearing Aid |
| Classification: | Hearing Aid, Air Conduction Panel 77, Procode<br>ESD, 874.3300, Class I |
| Intended Use: | This air conduction hearing instrument is intended to<br>amplify sound pressure waves and transmit the<br>signal to the external ear through the medium of air<br>to compensate for hearing losses of mild to<br>moderate degree. |
| Indications for<br>Use | Indications for use include persons with mild to<br>moderate hearing impairment depending upon<br>specific characteristics of the hearing loss and the<br>patient's environmental situations. |
| Substantially | The SONIC innovations Completely-in-the-Canal<br>DSP w/ |
| Equivalent to: | Soft Shell is substantially equivalent to the SONIC<br>innovations® CIC DSP hearing aid [510(k) not<br>required], the Decibel Instruments Articular<br>(inTune™) Hearing Aids [510(k) No. K964603], and<br>the Hearing Components Ad-Hear Comply<br>Disposable Earmolds [510(k)915794], i.e., it has the<br>SAME intended use and does not raise different<br>questions regarding safety and effectiveness. |
| Materials: | Assembled from standard hearing aid components<br>mounted with custom microchips. The hearing aid<br>soft shell is manufactured from biocompatible<br>materials that have been used in other medical<br>devices. |
| Technical<br>Characteristics: | Technical specifications are in accordance with<br>ANSI S3.22 1987. |
| Power source: | Standard Zinc-Air hearing aid battery, size 10. |
| Features: | The SONIC innovations Completely-in-the-Canal<br>DSP Hearing Aid with Soft Shell is a programmable<br>hearing aid with fully digital signal processing and<br>full dynamic range multiband compression<br>(multiplicative DSPTM) that allows independent<br>adjustment of gain and compression characteristics<br>within each frequency band from 250 to 8000 Hz.<br>The SONIC innovations hearing aid provides<br>database storage of patient information and hearing<br>aid fitting parameters. |
| Assembly: | The Soft Shell is removable and/or replaceable, and<br>can be cleared or replaced as needed. The shells<br>are offered in a few basic sizes and selected by the<br>hearing aid dispenser.<br><br>Except for the Soft Shell, the device is manufactured<br>and delivered completely assembled to the hearing<br>aid dispenser using materials and techniques widely<br>used by other manufacturers of hearing devices.<br><br>Two versions of the Soft Shell are available, both<br>made of biocompatible materials. The two versions<br>of the shell are available in multiple sizes, the<br>specific one being selected by the hearing aid<br>dispenser as suitable for an individual patient.<br><br>The Soft Shell may be cleaned and/or replaced as<br>needed by either the hearing aid dispenser or the<br>individual patient. |
| User Controls: | None |
| Programmability: | All parameters are digitally programmed via<br>proprietary software and the SONIC innovations<br>Hearing Aid Fitting and Programming System or HI-<br>Pro/Noah with PC or HI-Pro with PC. |

J. S. Johnson CONFIDENTIAL Page 102 of 103 Sonic Innovations, Inc. 5330 South 900 East, Suite 240 · Salt Lake City, Utah · 84117-7261 tel [phone] · fax [phone]

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510(k) Premarket Notification Sonic Innovations CIC DSP Hearing Aid

## A USER'S INSTRUCTION GUIDE AND ANSI TECHNICAL DATA ARE SUPPLIED WITH EACH HEARING AID.

J. S. Johnson Sonic Innovations, Inc. CONFIDENTIAL

Page 103 of 103

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Jeannette Seloover Johnson, Ph.D. Vice President, Research & Planning Sonic Innovations, Inc. 5330 South 900 East, Suite 240 Salt Lake City, Utah 84117-7261

Re:

K984518 SONIC Innovations® Completely-in-the Canal (CIC) DSP Hearing Aid with Soft Shell Dated: December 10, 1998 Received: December 21, 1998 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Dr. Johnson:

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). 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 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 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 requlation entitled, "Misbranding by reference to premarket notfication"(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/dsma/dsmamain.html".

Sincerely yours,

CART Daniel C. Schultz, M.D.

CAPT 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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| 510(k) Number (if known): | K984518 |
|---------------------------|---------|
|---------------------------|---------|

Sonic Innovations Completely-In-The-Canal

| Device Name: | DSP Hearing Aid with Softshell |
|--------------|--------------------------------|
|--------------|--------------------------------|

Indications For Use:

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A. General Indicacions:

The indication for use of the air conduction hearing aids in this file indication is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the folloving category(ies). (Check appropriate space(s)): I

| Severity: | |
|---------------------------------------------|--|
| ✓ 1. Slight | |
| ✓ 2. Mild | |
| ✓ 3. Moderate | |
| 4. Severe | |
| 5. Profound | |
| Configuration: | |
| ✓ 1. High Frequency - Precipitously Sloping | |
| ✓ 2. Gradually Sloping | |
| ✓ 3. Reverse Slope | |
| ✓ 4. Flat | |
| 5. Other | |
| Other | |
| ✓ 1. Low tolerance | |
| 2. | |
| 3. | |

B. Specific Indications (Only if appropriate.):

(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological 510(k) Number Rescricted device (per 21 CFR 801,420 & 21 CFR 801.421)