(81 days)
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.
Indications for use include persons with mild to moderate hearing impairment depending upon specific characteristics of the hearing loss and the patient's environmental situations.
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 following category(ies):
Severity: Slight, Mild, Moderate
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
Other: Low tolerance
The SONIC innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell is a programmable hearing aid with fully digital signal processing and full dynamic range multiband compression (multiplicative DSPTM) that allows independent adjustment of gain and compression characteristics within each frequency band from 250 to 8000 Hz. The SONIC innovations hearing aid provides database storage of patient information and hearing aid fitting parameters.
Assembled from standard hearing aid components mounted with custom microchips. The hearing aid soft shell is manufactured from biocompatible materials that have been used in other medical devices.
The Soft Shell is removable and/or replaceable, and can be cleared or replaced as needed. The shells are offered in a few basic sizes and selected by the hearing aid dispenser.
Except for the Soft Shell, the device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.
Two versions of the Soft Shell are available, both made of biocompatible materials. The two versions of the shell are available in multiple sizes, the specific one being selected by the hearing aid dispenser as suitable for an individual patient.
The Soft Shell may be cleaned and/or replaced as needed by either the hearing aid dispenser or the individual patient.
The provided text for the Sonic Innovations CIC DSP Hearing Aid (K984518) does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Premarket Notification summary that:
- Identifies the device.
- States its intended use and indications for use.
- Claims substantial equivalence to previously marketed devices.
- Lists technical characteristics in accordance with ANSI S3.22 1987.
- Describes the materials and features.
Crucially, it does not include any performance data, clinical trial results, or details of studies conducted to evaluate the device against specific performance benchmarks. The statement "Technical specifications are in accordance with ANSI S3.22 1987" implies compliance with a standard, but it doesn't provide the measured performance against that standard.
Therefore, I cannot fulfill your request for the tables and study details because the necessary information is not present in the provided text.
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510(k) Premarket Notification
Sonic Innovations CIC DSP Hearing Aid
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 801.288.0993 Fax 801.288.0998
| Classification Name: | Hearing Aid - Air Conduction |
|---|---|
| Common/Usual Name: | Hearing Aid |
| Proprietary Name: | SONIC innovations® Completely-in-the-Canal DSPHearing Aid with Soft Shell |
| Device Type: | Completely-in-the-Canal (CIC) Hearing Aid |
| Classification: | Hearing Aid, Air Conduction Panel 77, ProcodeESD, 874.3300, Class I |
| Intended Use: | This air conduction hearing instrument is intended toamplify sound pressure waves and transmit thesignal to the external ear through the medium of airto compensate for hearing losses of mild tomoderate degree. |
| Indications forUse | Indications for use include persons with mild tomoderate hearing impairment depending uponspecific characteristics of the hearing loss and thepatient's environmental situations. |
| Substantially | The SONIC innovations Completely-in-the-CanalDSP w/ |
| Equivalent to: | Soft Shell is substantially equivalent to the SONICinnovations® CIC DSP hearing aid [510(k) notrequired], the Decibel Instruments Articular(inTune™) Hearing Aids [510(k) No. K964603], andthe Hearing Components Ad-Hear ComplyDisposable Earmolds [510(k)915794], i.e., it has theSAME intended use and does not raise differentquestions regarding safety and effectiveness. |
| Materials: | Assembled from standard hearing aid componentsmounted with custom microchips. The hearing aidsoft shell is manufactured from biocompatiblematerials that have been used in other medicaldevices. |
| TechnicalCharacteristics: | Technical specifications are in accordance withANSI S3.22 1987. |
| Power source: | Standard Zinc-Air hearing aid battery, size 10. |
| Features: | The SONIC innovations Completely-in-the-CanalDSP Hearing Aid with Soft Shell is a programmablehearing aid with fully digital signal processing andfull dynamic range multiband compression(multiplicative DSPTM) that allows independentadjustment of gain and compression characteristicswithin each frequency band from 250 to 8000 Hz.The SONIC innovations hearing aid providesdatabase storage of patient information and hearingaid fitting parameters. |
| Assembly: | The Soft Shell is removable and/or replaceable, andcan be cleared or replaced as needed. The shellsare offered in a few basic sizes and selected by thehearing aid dispenser.Except for the Soft Shell, the device is manufacturedand delivered completely assembled to the hearingaid dispenser using materials and techniques widelyused by other manufacturers of hearing devices.Two versions of the Soft Shell are available, bothmade of biocompatible materials. The two versionsof the shell are available in multiple sizes, thespecific one being selected by the hearing aiddispenser as suitable for an individual patient.The Soft Shell may be cleaned and/or replaced asneeded by either the hearing aid dispenser or theindividual patient. |
| User Controls: | None |
| Programmability: | All parameters are digitally programmed viaproprietary software and the SONIC innovationsHearing Aid Fitting and Programming System or HI-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 801.288.0993 · fax 801.288.0998
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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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Image /page/2/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 and are left-aligned. The background of the image is plain and white.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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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:
Page 1 of 1
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.)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 874.3300 Air-conduction hearing aid.
(a)
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.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.