(48 days)
A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.
OPUS 2 - CANAL SERIES ( ITC )
This document is a 510(k) clearance letter from the FDA for the Opus 2 - Canal Series (ITC) hearing aid and does not contain the specific information required to answer the prompt.
The letter acknowledges the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, it does not include studies or data on acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of details would typically be found in the 510(k) submission itself, which is not provided here.
§ 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.