(21 days)
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Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
Yes
The device is described as a "hearing instrument" which amplifies and transmits sound to the ear, indicating it is used to treat or alleviate a hearing impairment.
No
The device is described as an amplification and transmission device for sound, specifically a hearing instrument. Its intended use is to aid hearing, not to diagnose a condition.
No
The device description explicitly states it is a "programmable behind-the-ear hearing instrument," which is a hardware device.
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 and transmit sound 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 to provide diagnostic information.
- Device Description: The description of a "Programmable behind-the-ear hearing instrument" further confirms its function as a hearing aid, which is not an IVD.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, this device falls under the category of a medical device, specifically a hearing aid, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments
Mentions image processing
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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
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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.
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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.
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
Exhibit 8
MAY 17 1996
and and and the little
ﻧﮯ
Summary of Safety and Effectiveness Information
| Name of device | : Phonak Piconet2 P2 AZ |
|---|---|
| Type of device | : Programmable behind-the-ear hearing |
| instrument. Substantially equivalent to other | |
| programmable behind-the-ear hearing | |
| instruments | |
| Intended Use | : To amplify and transmit sound to the ear |
| Features | : 3 programmable memories, telecoil, 5 forms of |
| output limiting, remote control | |
| Assembly | : Assembled from components available to |
| hearing instrument manufacturer. Delivered | |
| completely assembled to the dispenser | |
| Tech. Characteristics | : Technical specifications comply with ASA/ANSI |
| S3.2 - 1987 | |
| Fit | : Frequency response, gain, output are fit to the |
| individual audiogram | |
| Controls | : Both manually operated volume control with |
| on/off and/or remote control is available | |
| Power Source | : Standard hearing instrument battery, size 13 |
A user's manual and other information is supplied with each hearing instrument.