(29 days)
To amplify and transmit sound to the ear
Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments
The provided text describes a hearing instrument, the Phonak Sona P2. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert involvement, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot fulfill your request as the necessary information is not present in the input. The exhibit only provides a summary of the device's characteristics and intended use.
{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 programmablein-the-canal hearing instruments |
| Intended Use | : To amplify and transmit sound to the ear |
| Features | : 3 programmable memories, 5 forms of outputlimiting, remote control |
| Assembly | : Assembled from components available tohearing instrument manufacturer. Deliveredcompletely assembled to the dispenser |
| Tech. Characteristics | : Technical specifications comply with ASA/ANSIS3.2 - 1987 |
| Fit | : Frequency response, gain, output are fit to theindividual audiogram |
| Controls | : Operated with remote control |
| Power Source | : Standard hearing instrument battery, size 312 or10 |
A user's manual and other information is supplied with each hearing instrument.
§ 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.