(68 days)
These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe.
These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe. These devices are powered by a standard hearing aid battery (type 13). These devices are manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability to program digitally the fitting parameters of the hearing devices and the ability of . the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.
This document is a summary of safety and effectiveness for a hearing aid device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Specifically, the document discusses substantial equivalence to a predicate device based on features, intended use, and programming capabilities. It does not present performance metrics, study methodologies, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters, which appears to be a code or identifier. The sequence is "K960052". The characters are written in a cursive style with thick, dark strokes, suggesting the use of a marker or pen. The background is plain white, providing a clear contrast for the characters to stand out.
Image /page/0/Picture/1 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is written in a bold, sans-serif font, with the "R" slightly larger than the other letters. The words "HEARING HEALTH CARE" are written in a smaller, sans-serif font below the word "ReSound".
ReSound® Personal Hearing System BT2-ES, BT2-EV, and BT241
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the ReSound® Personal Hearing Systems BT2-EV, and BT241 to the predicate device, the ReSound® Personal Hearing System BT2-C, (marketed as the BT2-E Encore), 510(k) No. K943788, September 21, 1994, is based on the following:
- These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe.
- These devices are powered by a standard hearing aid battery (type 13). ●
- These devices are manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.
- The intended use, performance specifications, functions and operations of the ReSound® . Personal Hearing Systems BT2-ES, BT2-EV, and BT241 are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System BT2-E.
- The ability to program digitally the fitting parameters of the hearing devices and the ability of . the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.
§ 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.