(81 days)
No
The description focuses on traditional digital signal processing (DSP) and programmable features for adjusting gain and compression. There is no mention of AI, ML, or related concepts like training or test sets.
Yes
The device is a hearing instrument intended to compensate for hearing losses, which is a therapeutic purpose.
No
The device is described as a hearing instrument intended to amplify sound to compensate for hearing loss, not to diagnose a condition. Its function is to transmit amplified sound waves to the ear.
No
The device description explicitly states it is "Assembled from standard hearing aid components mounted with custom microchips" and includes a "Soft Shell manufactured from biocompatible materials," indicating it is a hardware device with embedded software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an air conduction hearing instrument. Its function is to amplify sound pressure waves and transmit them to the external ear to compensate for hearing loss. This is a physical intervention to aid hearing, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use clearly states it's for compensating for hearing losses and amplifying sound for individuals with impaired hearing. It does not mention any diagnostic purpose or analysis of biological samples.
- Device Description: The description details the components and function of a hearing aid, not a diagnostic testing device.
- Anatomical Site: The anatomical site is the external ear, which is where the device is worn and interacts with sound, not where biological samples are collected for analysis.
Therefore, the device described is a therapeutic device (a hearing aid) and not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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:
Severity:
✓ 1. Slight
✓ 2. Mild
✓ 3. Moderate
Configuration:
✓ 1. High Frequency - Precipitously Sloping
✓ 2. Gradually Sloping
✓ 3. Reverse Slope
✓ 4. Flat
Other
✓ 1. Low tolerance
Product codes
77 ESD
Device Description
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear Canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hearing aid dispenser, individual patient
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 DSP |
| Hearing Aid with Soft Shell | |
| Device Type: | Completely-in-the-Canal (CIC) Hearing Aid |
| Classification: | Hearing Aid, Air Conduction Panel 77, Procode |
| ESD, 874.3300, Class I | |
| 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. | |
| Indications for | |
| Use | 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. | |
| Substantially | The SONIC innovations Completely-in-the-Canal |
| DSP w/ | |
| Equivalent to: | Soft Shell is substantially equivalent to the SONIC |
| innovations® CIC DSP hearing aid [510(k) not | |
| required], the Decibel Instruments Articular | |
| (inTune™) Hearing Aids [510(k) No. K964603], and | |
| the Hearing Components Ad-Hear Comply | |
| Disposable Earmolds [510(k)915794], i.e., it has the | |
| SAME intended use and does not raise different | |
| questions regarding safety and effectiveness. | |
| Materials: | 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. | |
| Technical | |
| Characteristics: | Technical specifications are in accordance with |
| ANSI S3.22 1987. | |
| Power source: | Standard Zinc-Air hearing aid battery, size 10. |
| Features: | 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. | |
| Assembly: | 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. |
| User Controls: | None |
| Programmability: | All parameters are digitally programmed via
proprietary software and the SONIC innovations
Hearing 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
1
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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1 4 45 1 3
| 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)