(29 days)
Not Found
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on standard hearing aid technology.
No.
The device's intended use is to amplify and transmit sound to the ear, which describes a hearing aid, not a device used for therapy or treatment of a medical condition.
No
Explanation: The device's intended use is to "amplify and transmit sound to the ear," which describes a hearing aid. This function is assistive and therapeutic, not diagnostic. Diagnostic devices typically identify or detect a medical condition.
No
The device description explicitly states it is a "programmable in-the-canal hearing instrument," which is a physical 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 "Programmable in-the-canal hearing instrument" clearly identifies it as a hearing aid, which is a therapeutic device, not a diagnostic one.
- Lack of IVD Indicators: 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 used for treatment or assistance, not for in vitro diagnosis.
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)
Not Found
Device Description
Programmable in-the-canal hearing instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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/0 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '961653'. The characters are written in a dark ink, and the image has a white background. The handwriting appears to be somewhat rough.
Exhibit 8
Summary of Safety and Effectiveness Information
| Name of device | : Phonak Sona P2 |
|---|---|
| Type of device | : Programmable in-the-canal hearing instrument. |
| Substantially equivalent to other programmable | |
| in-the-canal hearing instruments | |
| Intended Use | : To amplify and transmit sound to the ear |
| Features | : 3 programmable memories, 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 | : Operated with remote control |
| Power Source | : Standard hearing instrument battery, size 312 or |
| 10 |
A user's manual and other information is supplied with each hearing instrument.