BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

• K Number: K011438
• Device Name: BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
• Manufacturer: ENTIFIC MEDICAL SYSTEMS, INC.
• Date Cleared: 2001-07-23 ( 74 days)
• Product Code: LXB
• Regulation Number: 874.3302
• Type: Traditional
• Panel: Ear Nose & Throat
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K042017

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 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.