(214 days)
The Cochlear Baha 6 Max Sound Processor is intended for the following patients and indications for use:
· Patient of any age for use with the Baha Softband (or headband) or Baha SoundArc. 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 3kHz) should be better than or equal to 55 dB HL.
· 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 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 deadness: 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 Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from an air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or midle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha Softband or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel through the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.
The Baha 6 Max Sound Processor is a modification of the previously cleared Baha 5 Power Sound Processor (K161123). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Softband, SoundArc, Baha Connect abutments, Baha Attract magnet, or the B1300 titanium implant. The Baha 6 Max Sound Processor does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system. The changes within culminate as the next generation Baha sound processor that provides recipients with moderate hearing loss, up to 55 dB, access to sound.
The Baha 6 Max Sound Processor will be supported by a new fitting software, Baha Fitting Software 6, and a new app, Baha Smart App.
The provided text describes the Cochlear Baha 6 Max Sound Processor and associated software (Cochlear Baha Fitting Software 6, Cochlear Baha Smart App) and states that they are substantially equivalent to their predicate devices. However, the document does not describe a study involving acceptance criteria and device performance as requested in the prompt.
The content focuses on a 510(k) summary, which outlines the device's indications for use, technological characteristics, and a comparison to a predicate device (Cochlear Baha 5 Power Sound Processor). It mentions "Performance Data" but only states that "Bench testing was conducted to compare the Baha 6 Max Sound Processor with the Baha 5 Power Sound Processor, including use with the predicate implant / abutment systems." It further states that "Substantial equivalence to the predicate device was accomplished through functionality and performance testing, hardware and interface testing, reliability and environmental testing, as well as system and subsystem level testing." Software verification and validation were also completed.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these specific details are not present in the provided text.
The document concludes that based on indications for use, technological characteristics, and performance data (without detailing the data itself or the acceptance criteria), the new device is substantially equivalent to the predicate.
§ 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.