Hearing LossNCT05086809
Investigation of an Updated Bone-anchored Sound Processor
A study testing Device A and Device B in people with Hearing Loss and Hearing Loss, Conductive, run by Oticon Medical at 1 site in Denmark.
Trial summary
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed
- What is being tested?
- Device A and Device B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Sep 2021to 13 Dec 2021
- 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
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects using a Ponto 3 SuperPower on Oticon Medical compatible abutment
- Experienced BAHS users with a minimum experience of 3 months.
- Subjects with:
- conductive or mixed hearing loss with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 65 dB HL as measured in situ with Ponto 3 SuperPower at Visit 1.
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- OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) as reported in the patient's Noah file.
- OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS (as per investigator discretion).
- Fluent in Danish
Who cannot join
- Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
- Known abnormally progressive BC hearing loss as judged by the investigator
- Subjects with known mixed losses where the sensorineural part of the hearing loss is of retro-cochlear or central origin
- Participation in another clinical investigation which might cause interference with study participation.
- Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BC109 - Investigation of an Updated Bone-anchored Sound Processor
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor.
The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.
Read the detailed description
The investigation is a premarket investigation with the purpose of gathering knowledge on the performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound processor to establish marketing claim(s) on the updated sound processor.
The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or single-sided deafness will be included.
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. The study includes four laboratory visits and three field trial periods. After the first trial period, which is included to ensure a homogenous baseline, the study is designed as a two-period, two-sequence crossover trial to compare the two sound processors (Device A \& Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
This study is designed to combine audiological assessments (hearing and speech tests) in the laboratory and subjective self-reported outcomes collected during and after field trial periods with the investigational device and the comparator device (Ponto 3 SuperPower). The primary outcome of this study is to demonstrate that Open Sound Navigator in the updated sound processor provides subjects with improved speech recognition in noise.
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Disorders, Deafness, Ear Diseases
- Being tested
- Device A, Device B
- Keywords
- BAHS, Ponto
- Medical subject headings
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Hearing Disorders, Deafness, Ear Diseases, Otorhinolaryngologic Diseases, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device ADevice
Participant wear Device A and evaluate the performance of the device.
Device BDevice
Participant wear Device B and evaluate the performance of the device.
| Study group | Role | What they receive |
|---|---|---|
| AAB | Active comparator | Starts with Device A in first and second trial period and change to Device B in third trial period. Receives: Device: Device A; Device: Device B |
| ABA | Active comparator | Starts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period. Receives: Device: Device A; Device: Device B |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).
Measured: 4 weeks or 6 weeks
Secondary outcomes (12)
To assess the preference of BAHS sound processor.
Percentage (%) of subjects who prefer Device A over Device B in noisy sound environments.
Measured: 6 weeks
To assess the improvement of hearing with Device A.
- Functional gain with Device A, i.e. the difference in dB between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
- Functional gain with Device A, see definition above, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Measured: Baseline
To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL
- Effective gain defined as the difference in dB between aided sound field thresholds with Device A, and BC in-situ thresholds on the aided ear(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
- Effective gain with Device A, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Measured: Baseline
To assess the improvement in speech recognition with Device A in quiet.
Difference in speech recognition score in percent between unaided and aided, assessed in quiet on the aided ear(s).
Measured: 2 weeks
To assess performance in speech recognition in noise with Device A and Device B in Omni settings.
Difference in SRT70 between Device A and Device B in Omni settings as measured at Visit 1.
Measured: Baseline
To assess the improvement in speech recognition in noise with Device B in full directional settings as compared to omnidirectional.
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between Omni and Full Dir after field trial with Device B.
Measured: 4 weeks or 6 weeks
To compare the improvement in speech recognition in noise with OSN ON in Device A (re Omni) with the improvement of full directionality in Device B (re Omni).
Comparison of the difference in SRT70 between OSN OFF vs. OSN ON in Device A and Omni vs. Full Dir in Device B.
Measured: 4 weeks or 6 weeks
To assess self-reported performance with Device A and Device B.
- Average SSQ12 scores with Device A for each question, sub-scales and in total.
- Average SSQ12 scores with Device B for each question, sub-scales and in total.
- Difference in SSQ12 scores between Device A and Device B for each question, sub-scales and in total.
Measured: 4 weeks or 6 weeks
To assess self-reported ratings of sound quality, speech intelligibility, and overall performance with Device A and Device B.
- Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 1. field trial with Device A as obtained via phone interview
- Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device A
- Average ratings with Device B for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device B
- Difference in ratings between Device A and Device B for each question of the "SPSK sound quality" questionnaire
- Average ratings with Device A for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device A
- Average ratings with Device B for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device B
- Difference in ratings between Device A and Device B for each question of the "SPSK situations" questionnaire
Measured: 1 week, 4 weeks and 6 weeks
To assess the difference in BC thresholds as measured in-situ with Device A and via conventional BC audiometry.
Difference in dB between BC in situ thresholds and BC thresholds measured with conventional BC audiometry.
Measured: Baseline and 2 weeks
To assess the difference in BC thresholds as measured in-situ with Device A and Device B.
Difference in dB between BC in situ thresholds measured with Device A and Device B.
Measured: Baseline
To confirm the safety profile of the Device A in terms of the occurrence of adverse events and serious adverse events.
Tabulated adverse events and serious adverse event related to the Device A reported throughout the study.
Measured: 1 week, 2 weeks, 4 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start30 Sep 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study includes four laboratory visits and three field trial periods. The first trial period is included to ensure a homogenous baseline. After the first trial period, the study is designed as a two-period, two-sequence crossover trial to compare two sound processors (Device A \& Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mona El Hichou, MSc, Principal investigator, Oticon Medical c/o Oticon A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086809
- Sponsor's protocol ID
- BC109
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BC109 - Investigation of an Updated Bone-anchored Sound Processor
- ClinicalTrials.gov ID
- NCT05086809
- Acronym / sponsor ID
- BC109
- Conditions
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Disorders, Deafness, Ear Diseases
- Keywords
- BAHS, Ponto
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 21 Oct 2021 (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 study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor.
The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.
Detailed description
The investigation is a premarket investigation with the purpose of gathering knowledge on the performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound processor to establish marketing claim(s) on the updated sound processor.
The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or single-sided deafness will be included.
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. The study includes four laboratory visits and three field trial periods. After the first trial period, which is included to ensure a homogenous baseline, the study is designed as a two-period, two-sequence crossover trial to compare the two sound processors (Device A \& Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
This study is designed to combine audiological assessments (hearing and speech tests) in the laboratory and subjective self-reported outcomes collected during and after field trial periods with the investigational device and the comparator device (Ponto 3 SuperPower). The primary outcome of this study is to demonstrate that Open Sound Navigator in the updated sound processor provides subjects with improved speech recognition in noise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study includes four laboratory visits and three field trial periods. The first trial period is included to ensure a homogenous baseline. After the first trial period, the study is designed as a two-period, two-sequence crossover trial to compare two sound processors (Device A \& Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
| Arm | Type | Receives |
|---|---|---|
| AAB | Active comparator | Device: Device A, Device: Device BStarts with Device A in first and second trial period and change to Device B in third trial period. |
| ABA | Active comparator | Device: Device A, Device: Device BStarts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects using a Ponto 3 SuperPower on Oticon Medical compatible abutment
- Experienced BAHS users with a minimum experience of 3 months.
- Subjects with:
Key exclusion criteria (5 listed)
- Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
- Known abnormally progressive BC hearing loss as judged by the investigator
- Subjects with known mixed losses where the sensorineural part of the hearing loss is of retro-cochlear or central origin
- Participation in another clinical investigation which might cause interference with study participation.
- Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
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 |
|---|---|---|
| Device AParticipant wear Device A and evaluate the performance of the device. | Device | AAB, ABA |
| Device BParticipant wear Device B and evaluate the performance of the device. | Device | AAB, ABA |
Primary outcome
To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
Time frame: 4 weeks or 6 weeks
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).
12 secondary outcomes
To assess the preference of BAHS sound processor.
Time frame: 6 weeks
To assess the improvement of hearing with Device A.
Time frame: Baseline
To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL
Time frame: Baseline
To assess the improvement in speech recognition with Device A in quiet.
Time frame: 2 weeks
To assess performance in speech recognition in noise with Device A and Device B in Omni settings.
Time frame: Baseline
To assess the improvement in speech recognition in noise with Device B in full directional settings as compared to omnidirectional.
Time frame: 4 weeks or 6 weeks
To compare the improvement in speech recognition in noise with OSN ON in Device A (re Omni) with the improvement of full directionality in Device B (re Omni).
Time frame: 4 weeks or 6 weeks
To assess self-reported performance with Device A and Device B.
Time frame: 4 weeks or 6 weeks
To assess self-reported ratings of sound quality, speech intelligibility, and overall performance with Device A and Device B.
Time frame: 1 week, 4 weeks and 6 weeks
To assess the difference in BC thresholds as measured in-situ with Device A and via conventional BC audiometry.
Time frame: Baseline and 2 weeks
To assess the difference in BC thresholds as measured in-situ with Device A and Device B.
Time frame: Baseline
To confirm the safety profile of the Device A in terms of the occurrence of adverse events and serious adverse events.
Time frame: 1 week, 2 weeks, 4 weeks and 6 weeks
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 20 Apr 2022.
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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.
Mona El Hichou, MSc principal investigator
Oticon Medical c/o Oticon A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device A and Device B in people with Hearing Loss and Hearing Loss, Conductive, run by Oticon Medical at 1 site in Denmark.
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 5 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 20 Apr 2022. 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 Denmark. 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?
To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise. (time frame: 4 weeks or 6 weeks). 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 20 Apr 2022.