(112 days)
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.
| Acceptance Criteria (Inferred from Predicate Device BAHA Divino) | Reported Device Performance (OBC Bone Anchored Hearing Aid System) |
|---|---|
| Design: Bone conduction sound processor connected to an implant surgically placed in the bone behind the deaf ear | Bone conduction sound processor connected to an implant surgically placed in the bone behind the deaf ear (Yes, substantially equivalent) |
| Intended Use: Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness | Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness (Yes, substantially equivalent) |
| Material: Implant: Titanium; Sound processor coupling: PEEK | Implant: Titanium; Sound processor coupling: PEEK (Yes, substantially equivalent) |
| Power Requirement: Zinc-air battery | Zinc-air battery (Yes, substantially equivalent) |
| Max Gain: 33dB | 33 dB (Yes, substantially equivalent) |
| Frequency Response: 125 Hz - 8 kHz | 125 Hz - 8kHz (Yes, substantially equivalent) |
| Sound Processing: Digital | Digital (Yes, substantially equivalent) |
| Safety and Efficacy: No new issues of safety and efficacy compared to predicate | No new issues of safety and efficacy compared to predicate (Concluded based on laboratory testing and comparison) |
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.
§ 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.