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The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

Device Description

The Bio-logic Insert Earphones are transducers that convert electrical stimulus, provided by the Bio-logic ABaer / Navigator Pro Auditory Evoked Response Stimulators, into acoustic stimulus, which is then coupled to the patient's ears. They are comprised of five sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Speaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

AI/ML Overview

The provided text describes the Bio-logic Insert Earphones and compares them to a predicate device, the Etymotic Research ER-3 Insert Earphones. The study presented is a non-clinical performance test to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements are not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical performance, the acceptance criterion implicitly is "substantial equivalence" to the predicate device in key output parameters, particularly sound level and frequency bandwidth.

Parameter for Comparison	Acceptance Criteria (Predicate: Etymotic Research ER-3)	Reported Bio-logic Insert Earphone Performance	Reported Bio-logic Broadband Insert Earphone Performance	Met Criteria?
1 kHz Sensitivity (re IEC 711 Coupler @ 1.0 Vrms AC Drive)	114 dB SPL	111 dB SPL	85 dB SPL	Yes (with calibration for standard, designed lower for broadband)
Frequency Bandwidth (± 5 dB) (re IEC 711 Coupler)	100 Hz – 4,000 Hz	100 Hz – 4,000 Hz	100 Hz – 10,000 Hz	Yes (same for standard, broader by design for broadband)
Intended Use	Auditory Evoked Response	Same	Same	Yes
Target Population	Infants, Children, and Adults	Same	Same	Yes
Human Factors	Simple, easy-to-follow instructions	Same	Same	Yes
Design	Transducer and circuit mounted in a case, cable connection, silicon sound tube and foam eartip	Similar physical design with different cable type and slightly different acoustics	Similar physical design with different cable type, transducer type, acoustics and filter to produce a broader band frequency response at a lower output	Yes
Energy Used and/or Delivered	Device is passive and consumes less than 0.5 Wpeak. Electrical energy converted to acoustic energy.	Same	Same	Yes
Standards Met	Associated with stimulation device	Same	Same	Yes
Bio-compatibility	All material passed bio-compatibility testing	Same	Same	Yes
Sterility	Not supplied sterile	Same	Same	Yes
Compatibility with Environment	No environmental issues	Same	Same	Yes
Chemical Safety	No chemicals involved in the use of this device.	Same	Same	Yes
Thermal Safety	Device does not contain any thermal producing components.	Same	Same	Yes
Mechanical Safety	Device does not contain any moving components.	Same	Same	Yes
Electrical Safety	Patient is isolated from device via silicon sound tube and foam eartip.	Same	Same	Yes

Note regarding "Met Criteria?": For the standard Bio-logic Insert Earphone, the differences in sensitivity were calibrated to achieve similar frequency response. For the Broadband Insert Earphone, the differences were by design to achieve a wider bandwidth. Both outcomes were deemed substantially equivalent based on the provided discussion.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This was a non-clinical laboratory test, not a study involving human subjects or collected data from a "test set" in the typical sense of a clinical trial. The "test set" comprised the Bio-logic Insert Earphone, the Bio-logic Broadband Insert Earphone, and the predicate Etymotic Research ER-3 Insert Earphones.
Data Provenance: Not applicable. The data was generated in a controlled laboratory setting (described as measuring sound level within a Bruel & Kjaer Type 711 Occluded Ear simulator). It is not retrospective or prospective clinical data from a specific country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the sense of expert consensus on clinical findings, is not relevant for this non-clinical engineering performance study. The "ground truth" here is the physical acoustic output measurements, which are objectively measurable by standard laboratory equipment.

4. Adjudication method for the test set

Not applicable. There was no need for human adjudication of test results, as the measurements were objective physical quantities.

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 was not a comparative effectiveness study involving human readers or AI.

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

Not applicable. This device is an earphone, not an algorithm, and does not involve AI or human-in-the-loop performance in the sense of diagnostic interpretation.

7. The type of ground truth used

The "ground truth" relevant to this submission is the objective physical measurement of acoustic output (sound level, frequency response) as measured by a Bruel & Kjaer Type 711 Occluded Ear simulator.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. As above, this is a physical device.

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