(57 days)
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No
The summary describes a simple FM transmission system for hearing aids, with no mention of AI, ML, or any related concepts.
No
The device is described as a personal FM unit that receives audio transmission and feeds it to a hearing aid, primarily for enhancing hearing in specific settings. It does not appear to treat or prevent a disease or condition, but rather aids in communication.
No
Explanation: The device is described as an FM transmission receiver that feeds audio to a hearing aid, intended to assist with hearing in environments like lecture halls. Its function is to transmit sound, not to diagnose any medical condition or disease.
No
The device description explicitly states it is a "Personal FM unit" that operates via an "audio input connection" to hearing instruments. This indicates a physical hardware component (the FM unit) is involved, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to receive FM transmission and feed it to a hearing aid for improved audio reception in settings like lecture halls. This is a device for assisting hearing, not for diagnosing a condition.
- Device Description: The description confirms it's a personal FM unit for use with hearing instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Phonak MicroLINK FM Receiver
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the word "PRONAK" in a bold, stylized font. Below the word, there is a tagline that reads "The Choice of Professionals". The text is black and the background is white.
K964035 DEC - 4 1996
Exhibit 4 A Summary of Safety and Effectiveness Information
Name of Device: Phonak MicroLINK FM Receiver
Type of Device: Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.
Intended use: To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.
Features/Controls: Switch for FM alone or FM/M input selection.
Assembly: Assembled from components available to hearing aid manufacturers. Delivered completely assembled to the dispenser or school.
Technical Characteristics: Technical specifications comply with part 90 FCC rules. Frequencies used are in the 216 MHz band.
Power source: Unit draws power from hearing aid battery.
A user's manual and other information is supplied with each instrument to the consumer.