(65 days)
The Cochlear Baha® 4 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 45 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 BP100 sound processor, which was cleared under 510(k) K090720 for unilateral 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 100,000 users of a Baha system globally.
Baha sound processors can be used with either the external Baha headband or Softband in persons of any age, 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 4 is an upgrade to the currently marketed Baha BP100 sound processor, which it will replace on the U.S. market. The Baha 4 sound processor is mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-theshelf electronic assembly used in currently marketed air conduction devices. The modified device utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device it will replace. In addition, the Baha 4 is compatible with certain 2.4GHz devices currently marketed for use with air conduction hearing aids.
The provided 510(k) summary for the Cochlear Baha 4 Sound Processor does not contain acceptance criteria or a study proving that the device meets specific performance criteria.
This document is a Special 510(k), indicating that the device is a modification of a previously cleared device (Cochlear BP100 sound processor, K090720). Special 510(k)s often focus on demonstrating that the modified device is substantially equivalent to the predicate device despite technological improvements, rather than presenting new clinical performance studies against specific acceptance criteria.
The summary states that the Baha 4 sound processor is "mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-the-shelf electronic assembly used in currently marketed air conduction devices." It also claims that the modified device "utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device it will replace."
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies because the information is not present in the provided text.
Here's what the document does provide and why it doesn't fit the requested format:
- Device Description and Technological Characteristics: It details the modifications made to the Baha BP100, primarily replacing the internal ASIC with a new electronic assembly from air conduction devices. These modifications allow for new features like 2.4GHz wireless connectivity, additional program slots, wind noise detection/reduction, 17-channel sound analysis, and automatic scene analysis.
- Intended Use and Indications for Use: These remain the same as the predicate device.
- Substantial Equivalence Claim: The crux of this 510(k) is the assertion that, despite the technological improvements, the Baha 4 sound processor "still has substantially equivalent function and technology, and the same intended use as the predicate Baha BP100 sound processor." This means the manufacturer is arguing that the new features do not raise new questions of safety or effectiveness and that existing performance data for the predicate device, or general understanding of the technology, applies.
In summary, the provided text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Details of a standalone algorithm performance study.
- Information on the type of ground truth used for a performance study.
- Sample size for a training set or how its ground truth was established.
This is typical for a Special 510(k) where the focus is on demonstrating substantial equivalence to a predicate device rather than conducting new efficacy or performance trials against novel 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.