(91 days)
The Cochlear Baha BP100 sound processor is intended for use with the Baha auditory osseointegrated implant (for children aged 5 and older, or adults), or with the Baha Headband or Baha Softband (no age limitations), 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 45 dB HL.
- Bilateral fitting of the BP100 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 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 airconduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
The Baha implant 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. Baha sound processors can also be fitted as external (non-implanted) bone-conduction vibrators with either the Baha Headband or Baha Softband as an alternative to a conventional bone-conduction hearing aid.
The Baha BP100 will be the newest addition to a current family of three marketed sound processors for use with the Baha auditory osseointegrated implant, or with the Baha Headband/Softband setup. In its initial release, it will provide a moderate gain ear-level sound processor that will serve as a premium-feature option to the currently marketed Baha Divino. At a later date, the BP100 platform may be used to provide a range of programmable products to meet end-user needs.
The provided text describes a 510(k) premarket notification for the Cochlear Baha BP100, a bone conduction hearing aid. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a de novo clinical study with specific acceptance criteria and performance metrics.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new clinical study. Instead, the primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing, legally marketed predicate devices.
The reported device performance is framed in terms of comparability to the predicate Baha Divino.
| Aspect of Performance/Comparison | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Gain/Output | To be "comparable to" or "essentially equivalent (or better) than" the Baha Divino sound processor. | "Bench testing shows that the gain/output of the Baha BP100 are comparable to those for the marketed Baha Divino sound processor..." |
| "Bench testing shows that the Baha BP100 is essentially equivalent (or better) than the Baha Divino in terms of gain/output..." | ||
| "Bench testing supports the proposed Indications For Use, since gain/output are equivalent to the Baha Divino..." | ||
| Intended Use | To have the "same Indications For Use" as the Baha Divino. | The BP100 offers gain/output comparable to the Baha Divino, and "Thus, it will be marketed for use for conductive or mixed hearing loss patients who have average bone-conduction thresholds up to |
§ 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.