(29 days)
The Cochlear Baha® BP110 Power sound processor has the following indications for use:
- Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
- 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 55 dB HL.
- Bilateral fitting is intended for patients who meet the 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: 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 subject of this Special 510(k): Device Modification is a modification to the Cochlear Baha® Intenso sound processor, which was cleared under 510(k) K081606 for unilateral or bilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 77,000 users of a Baha system globally.
Baha sound processors can be used with either the external Baha headband or Softband, or, for children aged 5 or older, with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. 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 surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via the skull bone directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.
The modified sound processor, the Baha BP110 Power is an upgrade to the currently marketed Baha Intenso sound processor, which it will replace on the U.S. market. The BP110 Power sound processor will provide a more modern device with technological innovations compared to the predicate Intenso. As the modified device utilizes the same fundamental scientific principles, and the same intended use and indications for use as the current legally marketed device it will replace, and merely represents improvements in features and the sound processing of the amplified sound that are the same as those used in another Cochlear Baha sound processor that has already been cleared for marketing for a less hearing-impaired population (the model BP100, cleared under K090720), we believe these modifications are appropriate for the Special 510(k) process.
The primary modifications proposed are technological improvements so that the BP110 Power will be digitally programmable, allow up to three user-selectable listening programs and measurement of direct bone conduction thresholds (through the sound processor) for greater accuracy in fitting, and provide a number of sound processing improvements and features that have already been cleared for another Baha sound processor intended for a less severely impaired population (the Baha BP100. cleared under K090720). Improvements in sound processing include multichannel, non-linear programmability, advanced automatic directionality, background noise management, active feedback cancellation, and position compensation. The BP110 Power can be fit with Baha Fitting Software (also previously cleared under K090702), which has proprietary amplification strategies for direct bone conduction delivery of amplified sound. The BP110 Power also has audible and visible indicators (LEDs and beeps) for monitoring the status of the sound processor, a Europlug for compatibility with standard accessories and mainstream FM devices, and tamper proof features for the pediatric population. These modifications will result in a device that will provide more individual flexibility and accuracy in fitting and an increased number of sound processing options and features currently found in air conduction hearing aids (Class I, Exempt).
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The document is a 510(k) summary for the Cochlear Baha® BP110 Power Sound Processor, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, technological characteristics, and details the FDA's clearance. It does not provide detailed performance study results against specific 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.