(29 days)
The Cochlear Baha® 5 Power Sound Processor is intended for the following patients and indications for use:
*Patient of any age for use with the Baha Softband. 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 intents 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. Singlesided 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 Baha 5 Power Sound Processor functions by combining the external sound processor with an abutment (the Connect system) or with a magnet (the Attract system) and small titanium implant that is placed in the skull behind the ear during a simple surgical procedure. The sound processor transmits acoustic signals into electrical signals which then causes mechanical action in the transducer to transmit sound transcranially to the functioning auditory system.
Unlike hearing aids, the Baha hearing system utilizes a natural bone conduction pathway to send sound directly to a cochlea with residual functionality. The Baha system combines an external sound processor, in this application the Baha Power Sound processor, with small titanium implant placed into the bone through a simple surgical procedure. The implant is either attached to the sound processor via an abutment or internal titanium-encased magnet paired with an external magnet. The implant subsequently forms an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear, bypassing a damaged outer or middle ear. The Baha system provides an alternate pathway for patients who may not benefit from wearing an air-conduction hearing aid.
The modified sound processor, the Baha 5 Power Sound Processor is an upgrade to the currently marketed BP110 Sound Processor (which it will replace on the US market) and the Baha 5 Sound Processor. The Baha 5 Power Sound Processor provides gain sufficient to match the Indications for Use of the currently marketed BP110 Sound Processor.
The provided text describes the Cochlear Baha 5 Power Sound Processor and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study or a study proving that the device meets specific acceptance criteria in the context of diagnostic performance or clinical effectiveness studies in humans.
Instead, the document details a 510(k) submission for a medical device (a hearing aid), which typically focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This is primarily established through:
- Indications for Use: Ensuring the new device has the same or very similar intended use.
- Technological Characteristics: Comparing materials, fundamental operating principles, and functional characteristics.
- Performance Data (Bench Testing): Demonstrating that the device performs as expected in controlled, non-human environments.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document refers to "bench testing" to compare the device to predicates and show functional equivalence, which is a different type of evaluation than what is typically associated with acceptance criteria for a study demonstrating clinical performance or diagnostic accuracy.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance (in a human study context).
- Sample size used for a test set and data provenance (for a human study).
- Number of experts used to establish ground truth or their qualifications (for a human study).
- Adjudication method (for a human study).
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone performance study (in a clinical context).
- Type of ground truth used (pathology, outcomes data, etc.) (for a human study).
- Sample size for a training set (as this is not an AI/algorithmic device in the typical sense of a training set).
- How ground truth for a training set was established.
The document's "Performance Data" section states: "Bench testing was conducted to compare the Cochlear Baha® 5 Power Sound Processor with the predicate implant / abutment systems. Substantial equivalence to the predicate devices was accomplished through environmental testing, reliability testing, electrical interface testing, and functional testing. The results demonstrated the Cochlear Baha 5 Power Sound Processor is functionally equivalent to the predicate devices."
This indicates engineering and functional tests, not clinical performance acceptance criteria or a clinical study in the way implied by your request.
§ 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.