(59 days)
The Baha Cordelle II sound processor is intended for use with the Baha auditory osseointegrated implant for the following patients and indications;
- . 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 65 dB HL.
- Bilateral fitting of the Cordelle II is intended for patients who meet the above e 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 or "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 system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality.
The Cordelle II is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the only analog signal processing and body-worn sound processor, and it offers the highest power output of all the devices.
The provided text describes the Baha® Cordelle II hearing aid, focusing on an expanded indication for use. Here's an analysis of the acceptance criteria and supporting studies based on the provided input:
Acceptance Criteria and Device Performance
The core of this submission is to expand the audiometric fitting range for the Baha Cordelle II. The original acceptance criterion for conductive and mixed hearing loss was a bone-conduction threshold of
§ 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.