(30 days)
The BAHA Divino is intended for the following patients and indications:
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Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz)
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Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies
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The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz
BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.
The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the Divino is based on a bone conduction technology.
The Divino hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.
Here's a breakdown of the acceptance criteria and study information for the BAHA Divino hearing aid, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Characteristic | BAHA-Branemark Bone Anchored Hearing Aid (Predicate) | BAHA Divino (Reported Device Performance) |
|---|---|---|
| Material (Implant) | Titanium | Same as BAHA (Titanium) |
| Material (Abutment Snap) | PEEK | Same as BAHA (PEEK) |
| Intended Use | Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness | Same as BAHA |
| Power Requirement | Zinc-air | Same as BAHA (Zinc-air) |
| Max Gain | 33dB | Same as BAHA (33dB) |
| Frequency Response | 125 Hz - 8 KHz | Same as BAHA (125 Hz - 8 KHz) |
| Sound Processing | Analogue | Digital |
| Manufacturer | Entific Medical Systems | Entific Medical Systems |
Study Details
The provided document describes a 510(k) Premarket Notification for the BAHA Divino. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to establish independent safety and effectiveness thresholds. Therefore, much of the information typically found in a clinical study report (like detailed sample sizes, expert qualifications for ground truth, MRMC studies, or standalone performance metrics) is not present in this document.
Here's what can be extracted and what is missing:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document mentions "software validation and functional testing" but does not provide details on specific test sets (patient data, etc.) or their provenance. This is typical for a 510(k) submission where the primary evidence is a comparison to a predicate device and technical verification/validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not explicitly stated. The submission relies on demonstrating technical and functional equivalence, not on a clinical "ground truth" validation against expert consensus on a patient cohort in the way a diagnostic AI might.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not explicitly stated. No clinical adjudication method is described.
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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. This is not an MRMC study. The device is a hearing aid, not a diagnostic AI system for image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the device has "digital sound processing," the document describes "software validation and functional testing" to verify functional equivalence. It doesn't present "standalone performance" in the context of an algorithm making a decision, but rather as a device performing its intended function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Functional equivalence to predicate device and internal technical specifications. The "ground truth" for this submission is that the BAHA Divino performs its intended function (sound amplification via bone conduction) in a manner substantially equivalent to existing BAHA devices and compliant with its own design specifications validated through software and functional testing. It is not based on a clinical "ground truth" related to disease detection or specific outcomes in a trial.
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The sample size for the training set:
- Not applicable/Not explicitly stated. As this is a medical device (hearing aid) and not an AI/ML model being "trained" on a dataset for prediction, there isn't a "training set" in the conventional sense of machine learning. The digital sound processing would be designed and validated based on engineering principles and performance specifications.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
Summary of the Study:
The "study" described in this 510(k) submission is primarily a comparison of the BAHA Divino to legally marketed predicate devices (previous BAHA models and air conduction hearing aids with digital sound processing) to demonstrate substantial equivalence.
- Focus: Substantial equivalence based on technological characteristics, intended use, and materials.
- Testing: Included "software validation and functional testing" to verify that the Divino is functionally equivalent to the predicate BAHA devices. The details of these tests (e.g., number of units tested, specific metrics) are not provided in this summary.
- Conclusion: Entific Medical Systems concluded that the BAHA Divino is substantially equivalent and presents no new concerns about safety and effectiveness. The FDA concurred with this determination.
Crucially, no new clinical trials or studies generating novel clinical evidence of safety or effectiveness are described, nor are they typically required for a 510(k) submission that demonstrates substantial equivalence to predicate devices for which safety and effectiveness have already been established.
§ 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.