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TransEar® is intended for individuals with single sided deafness or unaidable unilateral hearing loss, with single sided deafness being defined as an ear having one or more of the following characteristics:

1. Profound sensorineural hearing loss of such magnitude that there is no perceived benefit from an air conduction hearing aid coupled to the same ear.
2. A hearing loss greater than 50 dB HTL at frequencies of 500 Hz 4000 Hz with speech recognition ability less than 50% when presented in quiet, at a 40 dB sensation level relative to the user's speech reception threshold.
3. A hearing loss greater than 50 dB HTL at frequencies of 500 Hz 4000 Hz with a small dynamic range, for loudness less than 20 dB for amplified speech, which makes the use of an air conduction hearing aid intolerable to the user.
   The "better" cochlea should have pure tone air conduction thresholds 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 dB HTL or better at 3000 Hz.
   For individuals with a "better" ear that exhibits a mixed or conductive hearing loss, bone conduction thresholds should be 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 db HTL or better at 3000 Hz,

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This document is a 510(k) clearance letter for the TransEar® Bone Conduction Hearing Aid. It confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The paragraphs you provided primarily discuss the regulatory status of the device, the conditions for its marketing, and contact information for further inquiries. There is no mention of specific performance metrics, clinical study design, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a different document that details the device's technical specifications and the results of performance or clinical studies.

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The TransEAR™ Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.

TransEAR™ is a bone conduction hearing aid. Unlike conventional air-conduction hearing aids, which depend on acoustic coupling through the air, TransEAR™ utilizes bone conduction technology to transmit sound vibrations through the bones of the skull to the cochlea.

TransEAR™ consists of a processor and a transducer (oscillator) connected via a wire cable. TransEAR's processor uses conventional digital hearing aid technology housed in a conventional behind-the-ear aid housing. The transducer is a mechanical oscillator housed in a conventional ear mold made of standard ear mold material. Each ear mold is custom made from an impression of the wearer's ear. A standard Zinc-Air hearing aid battery is utilized for power.

The provided text describes a 510(k) premarket notification for the TransEAR™ Bone Conduction Hearing Aid, asserting substantial equivalence to predicate devices rather than providing a detailed study with acceptance criteria and device performance metrics. Such a submission focuses on demonstrating that a new device is as safe and effective as an already legally marketed device (predicate device) and does not typically include novel clinical studies with specific performance targets.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert qualifications, and specific performance metrics are not present in this type of regulatory document. The "study" here is essentially functional testing comparing the new device to existing ones.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of quantitative acceptance criteria or specific discrete performance metrics. Instead, "substantial equivalence" is the overarching acceptance criterion, evaluated based on intended use, function, design, materials, and performance compared to predicate devices. The "reported device performance" is a qualitative statement that "Results of this testing indicate that the TransEAR™ is substantially equivalent to the predicate devices."

2. 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 refers to "Functional testing" but does not detail the size of any test set (e.g., number of participants, amount of data) or the data provenance. In a substantial equivalence claim for a hearing aid, functional testing would likely involve technical performance measurements against industry standards or predicate device specifications, rather than a clinical trial with a large human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable and not provided. "Ground truth" in the context of this 510(k) is about demonstrating engineering and functional equivalence rather than clinical diagnostic accuracy requiring expert panel review.

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

Not applicable and not provided. Adjudication methods are typically used in studies where there is subjective interpretation of data (e.g., medical image analysis) to establish a consensus ground truth. This is not described for the functional testing.

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, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant here.

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

Not applicable in the AI sense. The device itself is a standalone functional device. The "functional testing" refers to the device's technical specifications and operation, not an algorithm's performance in isolation.

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

The concept of "ground truth" as typically discussed in diagnostic accuracy studies (e.g., pathology for imaging algorithms) is not directly applicable here. For a functional hearing aid, "ground truth" in the context of its performance would be established by objective measurements against established engineering and audiological standards. The document states that "Functional testing... was conducted. Results of this testing indicate that the TransEAR™ is substantially equivalent to the predicate devices." This implies comparison to the known performance of predicate devices and relevant standards.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not an AI/machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, there is no AI training set.

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