Hearing LossNCT04168229
A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids
A study testing Mermaid 9 ITE and Mermaid 9 BTE in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Mermaid 9 ITE and Mermaid 9 BTE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jul 2018to 13 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All classifications of hearing loss (sensorineural, conductive, mixed)
- If the hearing loss is conductive or mixed it must be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to severe
- German speaking
- Current hearing aid users
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- Both genders
- Ages 18 and older
- Ability and willingness to sign the consent form
Who cannot join
- Contraindications for amplification
- Active ear disease
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
- A reduced mobility making them unable to attend weekly study appointments
- Uncooperative so that it is not possible to record a valid pure tone audiogram
- A strongly reduced dexterity
Show all 9Show fewer
- Central hearing disorders
- Bernafon employees
- Family members of Bernafon employees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation of the Benefit of Directionality as a Function of Microphone Location: BTE Hearing Aids Versus ITE Hearing Aids
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.
Read the detailed description
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.
- Conditions
- Hearing Loss
- Being tested
- Mermaid 9 ITE, Mermaid 9 BTE
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mermaid 9 ITEDevice
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.
Mermaid 9 BTEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Mermaid 9 ITE |
| 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). Receives: Device: Mermaid 9 BTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of one month.
Secondary outcomes (1)
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.
Measured: Through study completion, an average of one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start12 Jul 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernafon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Simon, AuD, Principal investigator, Bernafon AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168229
- Sponsor's protocol ID
- BF003-1808
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of the Benefit of Directionality as a Function of Microphone Location: BTE Hearing Aids Versus ITE Hearing Aids
- ClinicalTrials.gov ID
- NCT04168229
- Acronym / sponsor ID
- BF003-1808
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bernafon AGIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ITE Hearing Aid | Experimental | Device: Mermaid 9 ITEThe 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). |
| BTE Hearing Aid | Active comparator | Device: Mermaid 9 BTEThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All classifications of hearing loss (sensorineural, conductive, mixed)
- If the hearing loss is conductive or mixed it must be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to severe
- German speaking
Key exclusion criteria (9 listed)
- Contraindications for amplification
- Active ear disease
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
- A reduced mobility making them unable to attend weekly study appointments
- Uncooperative so that it is not possible to record a valid pure tone audiogram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mermaid 9 ITEA Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and receiver housed in an in-the-ear hardware. | Device | ITE Hearing Aid |
| Mermaid 9 BTEA Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and Receiver housed in a behind-the-ear hardware. | Device | BTE Hearing Aid |
Primary outcome
Speech Intelligibility Performance
Time frame: Through study completion, an average of one month.
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.
Word Recognition
Time frame: Through study completion, an average of one month.
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.
1 secondary outcome
Subjective Performance of Aided Benefit
Time frame: Through study completion, an average of one month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Simon, AuD principal investigator
Bernafon AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mermaid 9 ITE and Mermaid 9 BTE in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Intelligibility Performance (time frame: Through study completion, an average of one month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.