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The current study will evaluate a new in-the-ear (ITE) hearing aid hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the behind-the-ear (BTE) hardware style with the ITE devices regarding the benefit received from different microphone locations.
Hearing aids constantly undergo incremental improvements from already marketed devices. The new devices are expected to perform as well or better than the previous ITE devices.
The aim of the testing is to grant quality control prior to product launch according to Bernafon development requirements.
The current study will evaluate a new ITE hearing aid hardware. The firmware driving the hearing aid has already been sold on the market using the BTE hardware for almost one year and will now be launched using the ITE custom hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the two hardware styles regarding the benefit received from different microphone locations.
As human subjects are involved the validation falls under the definition of a clinical investigation. The validation will address the performance of the new chip using the ITE hardware, and ensure that there is no reduction in speech understanding between using the BTE and ITE hardware styles. Evaluating the overall performance of the Mermaid 9 ITE devices is important to validate that the end user is satisfied with the devices and that all user requirements are fulfilled. All features available in Mermaid 9 have been validated and are currently used on the market in Mermaid 9 BTE devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITE Hearing Aid | Experimental | The subjects will wear the ITE devices in a field test for 10 +/-7 days. At the second and third visits they will perform speech testing in the lab in three randomized conditions (unaided, aided with ITE, and aided with BTE). |
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| BTE Hearing Aid | Active Comparator | The subjects will wear the BTE devices in a field test for 10 +/-7 days. At the second and third visits they will perform speech testing in the lab in three randomized conditions (unaided, aided with ITE, and aided with BTE). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mermaid 9 ITE | Device | A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and receiver housed in an in-the-ear hardware. |
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| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility Performance | Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the BTE device, and aided with the new ITE device. The test is the Oldenburg Sentence test (OLSA) and uses nonsense sentences. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 decibels (dB) and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB. | Through study completion, an average of one month. |
| Word Recognition | Word recognition test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the BTE device, and aided with the new ITE device. The test is called the Göttinger sentence test (GÖSA) and uses content relevant sentences that subjects repeat . The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 decibels (dB) and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB. | Through study completion, an average of one month. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Performance of Aided Benefit | The subjective performance for the new device will be measured with the APHAB questionnaire (Abbreviated Hearing Aid Benefit Profile). The questionnaire is a list of 24 statement that the subjects must agree or disagree with using a scale of units from A to G (A being Always and G being Never). Each letter has a corresponding score used for the calculation: A receives 99, B receives 87, C receives 75, D receives 50, E receives 25, F receives 12, and G receives 1. An average for each subscale is calculated, and a global or overall score can be calculated by taking the mean of the three positive subscales (Ease of communication, Background noise, and Reverberation). For these three subscales a higher score indicates a better performance. The highest possible score is 99 and the lowest is 1. The fourth scale (Aversiveness) is a negative scale meaning that a higher score means a worse performance. The highest possible score is 99 and the lowest is 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The number of adverse events reported including adverse events (AEs) related to the device will be used to measure the outcome. Adverse Events will be collected in an interview with the subjects during the Appointment. The minimum number of adverse Events possible is 0 and the maximum is infinite. A lower number means a better Outcome. | Through study completion, an average of one month. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Simon, AuD | Bernafon AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bernafon AG | Bern | 3018 | Switzerland |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 30, 2020 | |
| Reset | Aug 20, 2020 | |
| Release | Aug 26, 2020 | |
| Reset | Sep 16, 2020 | |
| Release | Jan 5, 2021 | |
| Reset | Jan 25, 2021 | |
| Release | Jul 1, 2022 | |
| Reset | May 2, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2018 | Nov 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2018 | Nov 11, 2019 | SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 30, 2020 | Aug 20, 2020 | |||
| Aug 26, 2020 |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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The study is a controlled, open-label, comparative trial using a cross-over design. The subjects first wore the BTE Hearing aids and then the ITE.
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Masking is not possible as the differences in hardware between the devices is obvious. The subjects and Investigator will recognize which device is the new one and which is the comparator.
| Mermaid 9 BTE | Device | A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and Receiver housed in a behind-the-ear hardware. |
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| Through study completion, an average of one month. |
| Unexpected device behavior | Subjects will a questionnaire to report unexpected behavior. A 5-point scale is used with 0 being the lowest answer possible (never occuring) and 5 being the highest answer possible (occuring often). A lower scale is a better score. | Through study completion, an average of one month |
| Sep 16, 2020 |
| Jan 5, 2021 | Jan 25, 2021 |
| Jul 1, 2022 | May 2, 2023 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |