(190 days)
The Baha Attract consists of a percutaneously placed Implant Magnet and an external Sound Processor Magnet forming a magnetic connection across healed skin. A Baha Sound Processor is then attached to the Sound Processor Magnet. The Baha Attract is indicated for conductive, mixed and single sided deafness. Patients should have sufficient bone quality and quantity to support successful implant placement.
The Cochlear Baha® Attract 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 3kHz) should be better than or equal to 45 dB HL for use with the BP100 sound processor, and 55 dB HL for use with the BP110 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-conductive 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 15dB 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: SSD™). 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.
The Baha Attract consists of a percutaneously placed Implant Magnet and an external Sound Processor Magnet forming a magnetic connection across healed skin. A Baha Sound Processor is then attached to the Sound Processor Magnet.
The provided document is a 510(k) clearance letter for the Cochlear Baha Attract/Osseointegrated Auditory system. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Instead, it states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance.
Therefore, I cannot extract the requested information from the provided text. The document does not describe the specific performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that would be present in a study report proving the device meets acceptance criteria.
§ 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.