BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)

• K Number: K021837
• Device Name: BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
• Manufacturer: ENTIFIC MEDICAL SYSTEMS, INC.
• Date Cleared: 2002-08-30 ( 87 days)
• Product Code: LXB
• Regulation Number: 874.3302
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: K955713

Intended Use

The use of BAHA hearing aid for SSD is intended to improve speech recognition.

The single sided deafness (SSD) indication for BAHA 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.

Device Description

The BAHA is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the BAHA is based on a bone conduction technology.

The BAHA 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Branemark Bone Anchored Hearing Aid (BAHA) for Single Sided Deafness (SSD), based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on the substantial equivalence determination for the BAHA for SSD. While it doesn't explicitly list "acceptance criteria" in a table format with numerical targets, the underlying assumption for substantial equivalence is that the device performs at least as well as or similarly to the predicate devices for its intended use.

The primary performance metrics assessed relate to improvement in hearing and speech recognition.

Acceptance Criteria (Implied by Substantial Equivalence and Intended Use)	Reported Device Performance (from Clinical Study)
Improvement of hearing for patients with SSD	A clinical study was conducted to establish the benefits of BAHA for SSD.
Improvement of speech recognition for SSD patients	Clinical study included audiometric evaluation of speech perception in noise.
Subjective improvement in daily listening situations for SSD patients	Clinical study included a subjective questionnaire (APHAB).

Study Details

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only states "A clinical study was conducted."

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 document. The study evaluated audiometric performance and subjective responses directly from patients, not through expert review of data that would require a ground truth panel.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. The study primarily relies on direct audiometric measurements and patient-reported outcomes (questionnaires), which do not typically involve adjudication in the same way as image interpretation studies.

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 MRMC comparative effectiveness study was done, as this device is a hearing aid, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. The BAHA is a medical device that physically aids hearing; it is not an algorithm, and its performance is inherently human-in-the-loop (the patient wearing it).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the effectiveness of the BAHA in this context would be:
     • Audiometric evaluation of speech perception in noise: Objective measures of how well patients could understand speech in challenging listening environments.
     • Subjective questionnaire (APHAB): Patient-reported outcomes on the benefit and satisfaction with the device in real-world situations.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set."

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

   • Not applicable. See point 7.

Regulation Number and Section

§ 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.