(60 days)
Not Found
Not Found
No
The description focuses on standard hearing aid technology (amplification, volume control, standard components) and does not mention any AI/ML terms or capabilities.
Yes
The device is an air conduction hearing aid intended to amplify sound for individuals with impaired hearing, which is a therapeutic function.
No
Explanation: The device is an air conduction hearing aid designed to amplify sound for individuals with impaired hearing. Its purpose is to assist hearing, not to diagnose a medical condition.
No
The device description explicitly mentions physical components like a volume control, on/off switch, and a standard hearing aid battery, indicating it is a hardware 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 Description: The description clearly states the device is an "Air Conduction Hearing Aid" that "amplifies and transmits sound to the ear." This is a device that interacts with the external environment (sound) and the ear, not with internal bodily samples.
- Intended Use: The intended use is to "amplify sound for individuals with impaired hearing." This is a therapeutic or assistive function, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indication for use of the air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories:
Severity : Slight , Mild , Moderate . . . . . . .
Configuration : High Frequency Precipitously Sloping , Gradual Sloping Reverse Slope , Flat
Product codes
77 ESD
Device Description
Name of Device: Scientific Plastics Model SP ITC Hearing Aid
Type of Device: Air Conduction Hearing Aid
Intended Use: To amplify and transmit sound to the ear.
Features: Volume Control. On/Off switch built into Volume Control.
Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers.
Technical Characteristics: Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the SP models are enclosed.
Fit: The frequency response of this product is dictated by the individual audiogram from each client.
Power: Standard hearing aid battery #312.
A user's manual and other information is supplied with each hearing aid.
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
Not Found
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)
Not Found
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
FEB 19 '97 04:25PM
JUN - 6 1997
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Name of Device: Scientific Plastics Model SP ITC Hearing Aid
| Type of Device:
Intended Use: | Air Conduction Hearing Aid
To amplify and transmit sound to the ear. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features: | Volume Control. On/Off switch built into Volume Control. |
| Assembly: | Assembled from standard components which are widely utilized by other
hearing aid manufacturers. |
| Technical
Characteristics: | Technical specifications were obtained in accordance with S3.22-1987
ANSI Specifications.
Preliminary data sheets for the SP models are enclosed. |
| Fit: | The frequency response of this product is dictated by the individual
audiogram from each client. |
| Power: | Standard hearing aid battery #312 |
.A user's manual and other information is supplied with each hearing aid.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Jeffrey Stegman …… Vice President Scientific Plastics, Inc. 243 W. 30th Street New York, NY 10001
Re: K971299 - - - - -Scientific Plastics ITC Model SP Dated: March 26, 1997 Received: April 7, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Stegman:
华
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 in a classification for your device and thus, permits your device to proceed to the market.
While your device has been deemed substantially equivalent to other legaily 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 temporarily ineffective for the wearer. Because electromagnetic interference 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 your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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3
Page 1 of 1
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510(k) Number (if known): _ K971299
Device Name: Scientific Plastics Model SP ITC Hearing Aid
Indications For Use:
The indication for use of the air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories :
m - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Severity : Slight , Mild , Moderate . . . . . . .
. ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Configuration : High Frequency Precipitously Sloping , Gradual Sloping Reverse Slope , Flat
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted device
Prescription Use (Psr 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
David G. Segerson
(Division Sign-Off)
1 Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number