(56 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep neural networks, training sets, or performance metrics typically associated with AI/ML models. The description focuses on standard hearing aid functionality.
Yes
The device is a hearing aid intended to amplify sound for individuals with impaired hearing, which is a therapeutic function.
No.
Explanation: The device is described as an "air conduction hearing aid" intended to "amplify sound for individuals with impaired hearing." Its function is to assist hearing, not to diagnose a condition.
No
The device is described as a "programmable in-the-canal hearing instrument," which is a hardware device that amplifies sound. The summary does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "amplify sound for individuals with impaired hearing." This describes a device that interacts with the body (the ear) to improve a physical function (hearing).
- Device Description: It's described as a "Programmable in-the-canal hearing instrument." This is a type of medical device, but not an IVD.
- Anatomical Site: The anatomical site is the "ear." IVDs typically analyze samples taken from the body (like blood, urine, tissue), not devices placed in the body to modify a function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting diseases or conditions through in vitro testing, or any of the typical characteristics of an IVD.
Therefore, this device is a hearing aid, which is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity:
X 1. Slight
X 2. Mild
X 3. Moderate
X 4. Severe
5. Profound
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
5. Other
Other
X 1. Low tolerance To Loudness
2.
3.
Product codes (comma separated list FDA assigned to the subject device)
77 ESD
Device Description
Type of Device: Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments
Features: Two programmable memories, 3 choices of signal processing, optional remote control
Assembly: Assembled from components available to hearing instruments manufacturer. Delivered completely assembled to the hearing aid dispenser
Technical Characteristics: Technical specifications comply with ANSI S3.22 - 1987
Audiometric Fit: Frequency response, gain, and output are fitted to the individual audiogram
Controls: Operated with remote control
Power Source: Standard hearing instrument battery, size 312
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hearing aid dispenser
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K972097 14
Exhibit 8
Summary of Safety and Effectiveness Information JUL 30 0 1997
| Name of Device: | Phonak MicroZoom P 2 |
|---|---|
| Type of Device: | Programmable in-the-canal hearing |
| instrument. Substantially equivalent to | |
| other programmable in-the-canal hearing | |
| instruments | |
| Intended Use: | To amplify and transmit sound to the ear |
| Features: | Two programmable memories, 3 choices |
| of signal processing, optional remote | |
| control | |
| Assembly: | Assembled from components available to |
| hearing instruments manufacturer. | |
| Delivered completely assembled to the | |
| hearing aid dispenser | |
| Technical Characteristics: | Technical specifications comply with |
| ANSI S3.22 - 1987 | |
| Audiometric Fit: | Frequency response, gain, and output are |
| fitted to the individual audiogram | |
| Controls: | Operated with remote control |
| Power Source: | Standard hearing instrument battery, size |
| 312 |
A user's manual and other information is supplied with each hearing instrument.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1997
Laura M. Voll, M.S. Regulatory Affairs Coordinator Phonak, Inc. 850 E. Diehl Rd. P.O. Box 3017 Naperville, IL 60566
Re: K972097 Phonak "MicroZoom P 2" Dated: May 30, 1997 Received: June 4, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Ms. Voll:
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 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 requirement, as set forth in the Quality System Regulation (OS) 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.
While your device has been decmed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporariiy ineffective for the wearer. Because electromagnetic interfarence may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of clectromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Willian Yin, Ph.D.
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
3
Device Name: MicroZoom P 2
Indications For Use:
General Indications: ....... . .......
The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
| Severity: | Configuration: | Other |
|---|---|---|
| X 1. Slight | X 1. High Frequency |
- Precipitously Sloping | X 1. Low tolerance
To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | 3. |
| X 4. Severe | X 4. Flat | |
| 5. Profound | 5. Other | |
B. Specific Indications (only if appropriate.): (Most psychoacuustic 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)
William Yin
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number .