(50 days)
To amplify and transmit sound to the ear. The VITA 160 Series Pocket Hearing Instruments (Models 162E, 166M and 168PP) are designed to provide amplification for a wide range of hearing losses, from moderate to profound.
Body (Pocket) Hearing Aid - Substantially equivalent to other Body worn (Pocket) hearing aids. Sound is transmitted from the body-worn amplifier to a non-custom earpiece through a standard electrical earphone cable. The VITA 162E and 166M medium power models both provide 132dB peak output and 65dB peak gain. They include a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. The VITA 166M medium power model additionally provides two controls for the dispenser to adjust: Low Frequency Tone (NH) and Maximum Power Output (PC). The VITA 168PP high power model provides 142dB peak output and 79dB peak gain. It includes a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. Three controls are provided for the dispenser to adjust: Low Frequency Tone (NH),Gain and Output Compression (AGC-O). Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. The frequency response of the product is included. Some adjustments may be made by the dispenser to adjust the amplification to the audiogram of the patient. User controls include an adjustable volume control wheel and an M-T-O 3 position toggle switch. Uses one standard AA Size battery.
This document, K962176, is a Premarket Notification (510(k)) for the Siemens VITA 160 Series Pocket Hearing Instruments, submitted to the FDA in 1996. It details the device's intended use, features, and technical characteristics to demonstrate substantial equivalence to other legally marketed body-worn hearing aids.
However, this document does not contain the type of information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what's missing:
- Focus of a 510(k): A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This often involves showing similar technological characteristics and performance specifications. It typically does not include a detailed clinical study with pre-defined acceptance criteria, especially for a device type like a hearing aid from 1996.
- Nature of the Device: Hearing aids amplify sound. Their "performance" is generally assessed by their acoustic output and how well they meet specifications like gain, frequency response, and maximum output. The concept of "acceptance criteria" for diagnostic accuracy (common in AI or imaging devices) is not applicable here.
- Information Provided:
- "Technical Characteristics: Technical specifications comply with S3.22-1987 ANSI Specifications." This is the closest thing to a performance standard. It indicates that the device's acoustic properties (e.g., gain, frequency response, output) meet the industry standard at the time. However, it's not a study report with acceptance criteria.
- No clinical study described: There is no mention of a study involving human subjects, a test set, ground truth, experts, or statistical analysis of performance outcomes against specific criteria.
Therefore, I cannot populate the requested table and details because the provided document does not contain this information. The K962176 is a notification of substantial equivalence based on technical specifications and comparison to predicate devices, not a report of a study designed to demonstrate performance against specific, pre-defined acceptance criteria with a designated test set and ground truth.
§ 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.