(21 days)
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No
The description focuses on traditional hearing aid technology (amplification, AGC-I, tone control, telecoil) and does not mention any AI or ML terms or functionalities.
No
The device amplifies and transmits sound to the ear, which functions as a hearing aid. While hearing aids can improve quality of life, they are generally considered assistive devices rather than therapeutic for a disease or condition in the medical sense, as they do not treat or cure a disease but rather compensate for an impairment.
No
Explanation: The device description states its purpose is to "amplify and transmit sound to the ear" and refers to it as a "hearing aid," indicating it is a therapeutic device designed to improve hearing, not to diagnose a condition.
No
The device description explicitly states it is a "BTE" (Behind-the-Ear) hearing aid with a "slim housing," "integrated amplifier," and a "three position, rotating switch," all of which are physical hardware components.
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 (the ear) to improve hearing, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a hearing aid, which is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a disease or condition
Therefore, this device falls under the category of a medical device, specifically a hearing aid, but 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
The Piccolo series of BTE's are a small compact hearing aid. It has incorporated in it's package a very slim housing that can be worn with glasses. The use of the new modern and small receiver enables the integrated amplifier to have better battery life with less distortion.The aid also has AGC-I, active low frequency tone control and a three position, rotating switch for Off-Telecoil-Microphone.
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.
0
NOV 27 1996
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name of Device: | Piccolo K-amp VC+, Piccolo P-A1, Piccolo ATC and Piccolo P-AO |
|---|---|
| Type of Device: | BTE Aid - Substantially equivalent to other BTE aids. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Features: | The Piccolo series of BTE's are a small compact hearing aid. It has incorporated in |
| it's package a very slim housing that can be worn with glasses. The use of the | |
| new modern and small receiver enables the integrated amplifier to have better | |
| battery life with less distortion.The aid also has AGC-I, active low frequency | |
| tone control and a three position, rotating switch for Off-Telecoil-Microphone. | |
| Assembly: | Assembled from standard components which are widely utilized by other |
| hearing aid manufacturers. | |
| Technical | |
| Characteristics: | Technical specifications comply with S3.22-1987 ANSI Specifications. |
| Preliminary data sheets for the Piccolo K-amp VC +, Piccolo P-A1, Piccolo ATC | |
| and the Piccolo P-AO are enclosed. | |
| Fit: | The frequency response of this product is dictated by the individual audiogram |
| from each client. | |
| Power: | Standard hearing aid battery: size 13 |
| A user's manual and other information is supplied with each hearing aid (enclosed). |