Search Results

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.

Ask a specific question about this device

The OBC is intended for the following patients and indications;

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kHz).
• Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5. 1. 2 and 4 kHz, or less than 15 dB at individual frequencies.
• Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The OBC bone anchored hearing aid system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The sound processor can alternatively be connected to headband accessories, to function as a conventional bone conductor.

This document is a 510(k) premarket notification for the Oticon Medical OBC Bone Anchored Hearing Aid System, seeking substantial equivalence to a predicate device, the BAHA Divino. The provided text primarily focuses on demonstrating substantial equivalence rather than presenting an extensive study with specific acceptance criteria and performance metrics typically found for novel device claims.

However, based on the information provided, we can infer the "acceptance criteria" relate to the functional and performance characteristics that need to be "substantially equivalent" to an existing, legally marketed device. The "study" here is essentially the comparison and verification process detailed in the submission.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly matching or performing equivalently to the predicate device, BAHA Divino. The "reported device performance" is the claim of equivalence.

2. Sample size used for the test set and the data provenance

The document states: "Laboratory testing of the OBC system was conducted to determine device functionality and conformance to design input requirements." However, it does not specify a sample size for a test set (e.g., number of patients or devices tested). It also does not mention data provenance in terms of country of origin or whether it was retrospective or prospective, as the testing described appears to be internal laboratory testing for functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is for substantiating equivalence based on technical specifications and functionality testing against a predicate device, not typical clinical performance evaluation requiring expert ground truth for a diagnostic or therapeutic outcome.

4. Adjudication method for the test set

Not applicable. There's no mention of an adjudication process as there isn't a clinical trial or performance study involving human interpretation of results requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hearing aid system, not an AI-powered diagnostic tool, and the submission does not describe an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a bone-anchored hearing aid, which requires human interaction (wearing and using it) and is not an algorithm-only standalone system. The "standalone" performance here refers to the device's functional characteristics as described in the comparison table.

7. The type of ground truth used

The "ground truth" in this context is the established functional and performance characteristics of the predicate device, BAHA Divino. The OBC system's performance was compared against these established characteristics using laboratory testing. The submission confirms that the "intended use, function and procedure" of the OBC are substantially equivalent to the BAHA Divino.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used in the conventional sense. The "training" for this device would refer to its design and engineering process, not data-driven model training.

9. How the ground truth for the training set was established

Not applicable. As above, there is no "training set" in the context of AI/ML device development.

Ask a specific question about this device