(22 days)
TransEar® is intended for individuals with single sided deafness or unaidable unilateral hearing loss, with single sided deafness being defined as an ear having one or more of the following characteristics:
- Profound sensorineural hearing loss of such magnitude that there is no perceived benefit from an air conduction hearing aid coupled to the same ear.
- A hearing loss greater than 50 dB HTL at frequencies of 500 Hz 4000 Hz with speech recognition ability less than 50% when presented in quiet, at a 40 dB sensation level relative to the user's speech reception threshold.
- A hearing loss greater than 50 dB HTL at frequencies of 500 Hz 4000 Hz with a small dynamic range, for loudness less than 20 dB for amplified speech, which makes the use of an air conduction hearing aid intolerable to the user.
The "better" cochlea should have pure tone air conduction thresholds 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 dB HTL or better at 3000 Hz.
For individuals with a "better" ear that exhibits a mixed or conductive hearing loss, bone conduction thresholds should be 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 db HTL or better at 3000 Hz,
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This document is a 510(k) clearance letter for the TransEar® Bone Conduction Hearing Aid. It confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The paragraphs you provided primarily discuss the regulatory status of the device, the conditions for its marketing, and contact information for further inquiries. There is no mention of specific performance metrics, clinical study design, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a different document that details the device's technical specifications and the results of performance or clinical studies.
§ 874.3302 Bone-conduction hearing aid.
(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.