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The Cochlear Baha® auditory osseointegrated implant system using model B1300 implant and model BA300 abutment is intended for the following patients and indications for use:

• Patients aged 5 and older.
• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1. 2, and 3 kHz) should be better than or equal to 45 dB HL for use with the BP100 sound processor, 55 dB HL for use with the Intenso sound processor, and 65 dB HL for use with the Cordelle II sound processor.
• Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies,
• Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness; SSDTM). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• Baha for SSD is also indicated for any patient who is indicated for an air conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

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This document is a 510(k) clearance letter from the FDA to Cochlear Americas for their Baha® Auditory Osseointegrated Implant System. It primarily addresses the substantial equivalence of the device to legally marketed predicate devices and outlines the indications for use. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study from the provided document. The document is typical of regulatory clearance letters, focusing on regulatory compliance rather than detailed study results or performance metrics against specific acceptance criteria.

To answer your questions, I would need a different type of document, such as a study report, clinical trial results, or a more detailed technical submission for the device.

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