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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:

1. Profound sensorineural hearing loss of such magnitude that there is no perceived benefit from an air conduction hearing aid coupled to the same ear.
2. 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.
3. 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.

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This product is used by hearing aid users as an accessory to remove Inis product is about by nearing overnight while they sleep.

A hearing aid drying appliance is an accessory for use by hearing aid users to remove moisture that collects in the hearing aid during normal use. Various products, most using a desiccant, have been in use for many years. Dry & Store uses a desiccant, a fan, and heat all common technologies - to remove much of the moisture. Along with drying, the product features a sanitizing cycle using a 4-watt ultraviolet bulb, commonly in use for a number of applications outside the hearing aid accessory market.

The provided document is a 510(k) summary for the "Dry & Store Hearing aid drying appliance." This document focuses on establishing substantial equivalence to existing devices and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary explicitly states:
"The manufacturer makes no claims as to degree of dryness, humidity level claimed after a drying cycle, or any other claim that suggests a minimum performance level."

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document is primarily concerned with regulatory clearance based on substantial equivalence, not performance validation against specific metrics.

Ask a specific question about this device