(221 days)
This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification. Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45 dB HL. (Patients with bone conduction thresholds between 25 and 45 dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following:
- Chronic otitis media (COM), or
- Congenital malformation (CM) of the middle/external ear; or
- Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.
Additional indications to be met by perspective BAHA candidates: - Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.
- For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.
The Branemark Bone-Anchored Hearing Aid (BAHA) System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, various accessories necessary for the placement and use of the fixture/abutment pillar, and a sound processor which is attached to the abutment. The fixture/abutment pillar is used as an anchor for the sound processor.
The provided text is related to a 510(k) submission for the Branemark Bone-Anchored Hearing Aid (BAHA™) System. This document focuses on regulatory approval and indications for use, rather than a clinical study evaluating specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance statistics is not present in the given text.
Based on the provided information, I can offer the following:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a way that would fit into such a table. It describes the intended use and expected outcomes (e.g., "expected to improve," "restored hearing levels in the normal range") rather than quantifiable performance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study with a specified sample size or data provenance. The information provided is for a 510(k) submission seeking clearance based on substantial equivalence to predicate devices, not a new clinical trial reporting performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document does not describe a clinical study involving experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. The document does not describe a clinical study with an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. The document does not describe an MRMC study.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. The device described is a medical implant and sound processor, not an artificial intelligence algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of an AI/algorithm performance study. The "ground truth" for the device's efficacy is implied by its ability to amplify sound and improve hearing based on its mechanism of action and prior clinical experience with similar devices, as described in the predicate products.
8. The Sample Size for the Training Set
Not applicable. The document does not describe a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable.
In summary, the provided 510(k) document is a regulatory submission focused on the safety and effectiveness of a medical device (a bone-anchored hearing aid) and its indications for use, including an expansion to pediatric patients. It establishes substantial equivalence to previously cleared predicate devices but does not detail a new clinical study with specific performance acceptance criteria or detailed study methodologies as would be expected for demonstrating algorithm performance.
§ 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.