(19 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a standard hearing aid.
No
The device amplifies and transmits sound, which is a functional aid, but it does not treat or cure a medical condition.
No
Explanation: The device's intended use is to amplify and transmit sound for hearing, not to identify or diagnose a medical condition. It functions as a hearing aid, which is a therapeutic device.
No
The device is described as a "Behind-The-Ear Hearing Aid," which is a physical hardware device designed to amplify and transmit sound. The summary does not mention any software-only components or functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To amplify and transmit sound via air conduction to the ear." This describes a device that interacts with the body to improve hearing, not a device used to examine specimens from the body (like blood, urine, or tissue) to diagnose diseases or conditions.
- Device Description: A "Behind-The-Ear Hearing Aid" is a medical device designed to assist hearing, not to perform in vitro diagnostic tests.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological specimens.
- Detecting or measuring substances in specimens.
- Providing information for diagnosis, monitoring, or screening of diseases.
IVD devices are specifically designed to be used outside the body to examine specimens from the body. This device operates on the body to improve a physiological function.
N/A
Intended Use / Indications for Use
To amplify and transmit sound via air conduction to the ear.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
- Type of Device: Behind-The-Ear Hearing Aid. Substantially equivalent to other behind-the-ear hearing aids.
- Three fitter controls Cross over frequency, low channel gain, Features: and threshold knee point. Two channel compression circuitry. Class D circuitry for excellent battery life. Telecoil with pre-amplifier. Directional Microphone.
- Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
- Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987.
- Fit: Hearing aid adjustment dictated by individual audiogram.
- Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
- Power : Standard hearing aid battery - size 13.
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): 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
Image /page/0/Picture/1 description: The image shows the logo for UNITRON INDUSTRIES INC. The word "UNITRON" is in large, bold, sans-serif font on the top line. Below that, in a smaller font, is the word "INDUSTRIES" followed by "INC."
NOV 27 1996
A Summary of Safety and Effectiveness Information
Unitron Industries, Sound F/XD *4 Name of Device:
- Type of Device: Behind-The-Ear Hearing Aid. Substantially equivalent to other behind-the-ear hearing aids.
- Intended Use: To amplify and transmit sound via air conduction to the ear.
- Three fitter controls Cross over frequency, low channel gain, Features: and threshold knee point. Two channel compression circuitry. Class D circuitry for excellent battery life. Telecoil with pre-amplifier. Directional Microphone.
- Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
- Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987.
- Fit: Hearing aid adjustment dictated by individual audiogram.
- Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
- Power : Standard hearing aid battery - size 13.
A user's guide and other information is supplied with each hearing aid.