Hearing LossNCT03498274
A Comparison of a Currently Marketed Hearing Aid Programmed With Two Different Fitting Methods
A study testing Fitting System and Traditional Fitting System in people with Hearing Loss, run by Bernafon AG at 2 sites in Switzerland.
Trial summary
This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life when fitted with two different methods. Subjective and objective evaluations will be made. 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?
- Fitting System and Traditional Fitting System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 19 Mar 2018to 11 Jun 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 types of hearing loss (sensorineural, conductive, mixed)
- If the hearing loss is conductive or mixed it must first be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to severe
- First time hearing aid users (never worn hearing aids before)
- German speaking
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- Both genders
- Ages 18 and older
- Ability and willingness to sign the consent form
Who cannot join
- Current hearing aids users
- 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 unable to attend weekly study appointments
- A reduced ability to describe auditory impressions and the usage of the hearing aids
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- Uncooperative so that it is not possible to record a valid pure tone audiogram
- A strongly reduced dexterity
- With psychological problems
- Central hearing disorders
- Bernafon employees
- Family members of Bernafon employees
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Comparative, Controlled, Clinical Investigation of a Currently Marketed Hearing Aid When Programmed With Two Different Fitting Methods
This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life when fitted with two different methods. Subjective and objective evaluations will be made. The aim is to show the benefits of the hearing aids with both fitting methods with the help of data obtained, and to improve the available fitting methods in order to further increase the benefit for people with hearing disorders in situations where the standard method and those trained to perform it are not available.
Read the detailed description
Benefits of amplification and accessories used with it outweigh anticipated risks in mild to profound hearing impaired subjects. The basic benefit of amplification should be present with any method that the trained professional fitting the instruments uses. The goal of this study is to compare two fitting methods and determine whether the end user perceives more benefit from one fitting method over the other. The objective benefit is expected to be the same; however, the subjective benefit may be different due to a possible psychological effect from more effort or time spent by the trained professional.
Bernafon will conduct this clinical investigation to test current hearing instruments fitted with the standard procedure and a self-directed procedure. Safety and performance validation of the new self-directed fitting software is needed before release to the market.
The reason for this study is to evaluate a currently marketed, CE certified, hearing aid and determine whether different fitting methods provide the same perceived benefit. Additionally, this study will validate the safety of the fitting procedure as well as collect post market safety information about the devices themselves. The goal is to evaluate the audiological performance objectively as well as the subjective benefit. Furthermore, it is important to identify unexpected, unwanted behavior from the fitting software and the devices.
- Conditions
- Hearing Loss
- Being tested
- Fitting System, Traditional Fitting System
- Keywords
- Fitting
- Medical subject headings
- Hearing Loss, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitting SystemDevice
End users will drive the screening and fitting flow; however, a trained professional is intended to assist them and help with explanations and the actual fitting of the hearing aids on the person. For a first time user the physical act of placing the hearing aid in/on the ear may create confusion. Therefore, the software is designed for an assistant to guide the user through the process and help with specific parts of the fitting or any questions in general.
Traditional Fitting SystemDevice
The trained professional will fit the hearing aids with the traditional software that is currently used on the market. They will not involve the patient except to play demonstration tones.
| Study group | Role | What they receive |
|---|---|---|
| Fitting System | Experimental | a self-directed hearing screening based on a known algorithm from Audiology Inc. sold in an automated audiogram by Grason Stadler, GSI and a simplified version of the software. The flow of the new software is driven by the end user, but a trained professional should always assist with the fitting. The new software will first perform a hearing screening on the end user and then recommend a hearing aid and prescribe amplification to the hearing aid based on the hearing screening results. Receives: Device: Fitting System |
| Traditional Fitting System | Active comparator | A traditional fitting method will be used as a control. This system is controlled by a trained professional, who performs the entire fitting without much interaction from the end user. The hearing instruments will be fit with the same settings as the experimental arm. Receives: Device: Traditional Fitting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA)
The answers to the questionnaire will be compared for each fitting method to determine if the subjective hearing aid benefit is as good when using the IMD as with the RMD. There is no numerical outcome.
Measured: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
Secondary outcomes (2)
Assessment of speech understanding with a standardized speech test that uses the percentage of words correct to score the performance.
A standardized speech test will be given after each field test to compare the two fitting methods. Percentage of correct words repeated from both fitting methods will be compared to determine whether one method helped the subjects to achieve higher speech scores.
Measured: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
Assessment of hearing aid preference with a questionnaire
To assess if the subjects prefer one hearing aid over the other they will complete a preference questionnaire that asks specifically which hearing aid they preferred and why. There is no point scale just a selection of Hearing aid 1 or hearing aid 2.
Measured: Time frame to assess change is one month after the hearing aids have been worn with both fitting methods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start19 Mar 2018
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Why it stopped: Insufficient recruitmen
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a controlled, randomized, cross-over, open label, comparative clinical investigation. A randomized cross-over design is used with half of the test subjects wearing the device fit with the traditional fitting method first and the other half using the self-directed method and then switching after approximately 10 +/-5 days.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernafon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Simon, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498274
- Sponsor's protocol ID
- BF002-1707
- Status last verified
- Jan 2019
- First submitted
- 28 Feb 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cox RM, Stephens D, Kramer SE. Translations of the International Outcome inventory for Hearing Aids (IOI-HA). Int J Audiol. 2002 Jan;41(1):3-26. doi: 10.3109/14992020209101307. No abstract available.
PubMed 12467365
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Controlled, Clinical Investigation of a Currently Marketed Hearing Aid When Programmed With Two Different Fitting Methods
- ClinicalTrials.gov ID
- NCT03498274
- Acronym / sponsor ID
- BF002-1707
- Conditions
- Hearing Loss
- Keywords
- Fitting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitmen
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bernafon AGIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 13 Apr 2018 (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.
This study is designed to investigate the benefits of the hearing aid in the laboratory and in daily life when fitted with two different methods. Subjective and objective evaluations will be made. The aim is to show the benefits of the hearing aids with both fitting methods with the help of data obtained, and to improve the available fitting methods in order to further increase the benefit for people with hearing disorders in situations where the standard method and those trained to perform it are not available.
Detailed description
Benefits of amplification and accessories used with it outweigh anticipated risks in mild to profound hearing impaired subjects. The basic benefit of amplification should be present with any method that the trained professional fitting the instruments uses. The goal of this study is to compare two fitting methods and determine whether the end user perceives more benefit from one fitting method over the other. The objective benefit is expected to be the same; however, the subjective benefit may be different due to a possible psychological effect from more effort or time spent by the trained professional.
Bernafon will conduct this clinical investigation to test current hearing instruments fitted with the standard procedure and a self-directed procedure. Safety and performance validation of the new self-directed fitting software is needed before release to the market.
The reason for this study is to evaluate a currently marketed, CE certified, hearing aid and determine whether different fitting methods provide the same perceived benefit. Additionally, this study will validate the safety of the fitting procedure as well as collect post market safety information about the devices themselves. The goal is to evaluate the audiological performance objectively as well as the subjective benefit. Furthermore, it is important to identify unexpected, unwanted behavior from the fitting software and the devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a controlled, randomized, cross-over, open label, comparative clinical investigation. A randomized cross-over design is used with half of the test subjects wearing the device fit with the traditional fitting method first and the other half using the self-directed method and then switching after approximately 10 +/-5 days.
| Arm | Type | Receives |
|---|---|---|
| Fitting System | Experimental | Device: Fitting Systema self-directed hearing screening based on a known algorithm from Audiology Inc. sold in an automated audiogram by Grason Stadler, GSI and a simplified version of the software. The flow of the new software is driven by the end user, but a trained professional should always assist with the fitting. The new software will first perform a hearing screening on the end user and then recommend a hearing aid and prescribe amplification to the hearing aid based on the hearing screening results. |
| Traditional Fitting System | Active comparator | Device: Traditional Fitting SystemA traditional fitting method will be used as a control. This system is controlled by a trained professional, who performs the entire fitting without much interaction from the end user. The hearing instruments will be fit with the same settings as the experimental arm. |
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 types of hearing loss (sensorineural, conductive, mixed)
- If the hearing loss is conductive or mixed it must first be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to severe
- First time hearing aid users (never worn hearing aids before)
Key exclusion criteria (12 listed)
- Current hearing aids users
- 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 unable to attend weekly study appointments
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 |
|---|---|---|
| Fitting SystemEnd users will drive the screening and fitting flow; however, a trained professional is intended to assist them and help with explanations and the actual fitting of the hearing aids on the person. For a first time user the physical act of placing the hearing aid in/on the ear may create confusion. Therefore, the software is designed for an assistant to guide the user through the process and help with specific parts of the fitting or any questions in general. | Device | Fitting System |
| Traditional Fitting SystemThe trained professional will fit the hearing aids with the traditional software that is currently used on the market. They will not involve the patient except to play demonstration tones. | Device | Traditional Fitting System |
Primary outcome
Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA)
Time frame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
The answers to the questionnaire will be compared for each fitting method to determine if the subjective hearing aid benefit is as good when using the IMD as with the RMD. There is no numerical outcome.
2 secondary outcomes
Assessment of speech understanding with a standardized speech test that uses the percentage of words correct to score the performance.
Time frame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4
Assessment of hearing aid preference with a questionnaire
Time frame: Time frame to assess change is one month after the hearing aids have been worn with both fitting methods.
Results and safety
The study was stopped early (reason given: Insufficient recruitmen). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 12467365Cox RM, Stephens D, Kramer SE. Translations of the International Outcome inventory for Hearing Aids (IOI-HA). Int J Audiol. 2002 Jan;41(1):3-26. doi: 10.3109/14992020209101307. No abstract available.
- 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 principal investigator
Employee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitting System and Traditional Fitting System in people with Hearing Loss, run by Bernafon AG at 2 sites 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 12 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: stopped early, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Insufficient recruitmen). Results are not available in the source record.
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?
Assessment of subjective benefit with the standardized questionnaire, International Outcome Inventory For Hearing Aids (IOI-HA) (time frame: Time frame to assess change is one month with the first measure after two weeks and the second week 3-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498274, which also lists 1 linked publication.
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 23 Jan 2019.