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The Baha Cordelle II sound processor is intended for use with the Baha auditory osseointegrated implant 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 65 dB HL.
• Bilateral fitting of the Cordelle II is intended for patients who meet the above e 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 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 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.

The Cordelle II is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the only analog signal processing and body-worn sound processor, and it offers the highest power output of all the devices.

The provided text describes the Baha® Cordelle II hearing aid, focusing on an expanded indication for use. Here's an analysis of the acceptance criteria and supporting studies based on the provided input:

Acceptance Criteria and Device Performance

The core of this submission is to expand the audiometric fitting range for the Baha Cordelle II. The original acceptance criterion for conductive and mixed hearing loss was a bone-conduction threshold of < 45 dB HL. The proposed expanded criterion is < 65 dB HL.

Study Information for Device Performance

The submission relies on published clinical data to support the expanded indications for use.

1. Sample size used for the test set and the data provenance:

   • The document refers to studies by van der Pouw et al. (1998), Tjellstrom et al. (2001), and Bosman et al. (2006). The specific sample sizes for these individual studies are not provided in the given text.
   • Data Provenance: The studies are "published clinical data" and "studies that were not sponsored by the applicant." This suggests they are retrospective analyses of existing patient data or prospective clinical trials conducted independently of Cochlear Americas. The countries of origin for the data are not explicitly stated, but authors' affiliations in the references (e.g., Scandinavian Audiology, International Journal of Audiology, Otolaryngologic Clinics of North America) suggest an international context, likely including European data.

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

   • This information is not provided in the submission. Since the device is a hearing aid and the studies likely focus on audiological outcomes, the "ground truth" would implicitly be established through standard audiological assessments (e.g., pure tone audiometry, speech perception tests) conducted by qualified audiologists and/or ENT physicians, but the specific number or qualifications of these experts are not detailed in the context of establishing a specific ground truth for a test set for this submission.

3. Adjudication method for the test set:

   • Not applicable / Not provided. The studies referenced are clinical performance studies, not typically involving an adjudication panel for a test set in the way an imaging AI algorithm might. The outcomes are based on measurable audiological data.

4. 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:

   • No, an MRMC study was not done. This is not an AI-based device, nor is it an imaging device requiring human reader interpretation. The studies focus on the direct clinical effectiveness of the device itself by measuring audiological improvement.

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

   • Not applicable. The Baha Cordelle II is a physical hearing aid that works in conjunction with a patient's auditory system. Its performance is measured in a human-in-the-loop context (i.e., when worn by a patient).

6. The type of ground truth used:

   • The "ground truth" for these clinical studies implicitly relies on audiological outcome measures. This would include:
     • Pure-tone average bone-conduction thresholds.
     • Hearing level (dB HL) measurements.
     • Potentially speech recognition scores or other functional hearing assessments.
   • These are considered clinical outcomes data directly reflecting the patient's hearing ability with the device.

7. The sample size for the training set:

   • Not applicable. The Baha Cordelle II is an analog hearing aid, not a machine learning algorithm that requires a "training set." The device's design and functionality are based on established audiological principles and hardware, not iterative training on data.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in this context. The device's performance relies on its physical and electronic design to process sound effectively.

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