Deafness; Sensoneural Single SidedNCT03848910
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
A study testing Investigational device - Sound Processor in people with Deafness; Sensoneural Single Sided and Conductive Hearing Loss, run by Cochlear at 1 site in Australia.
Trial summary
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- What is being tested?
- Investigational device - Sound Processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Feb 2019to 23 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Completed clinical investigation CBAS5539, and an active user of the Osia System.
- Signed Informed consent.
- Subject with conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB HL.
- OR subject with single-sided sensorineural deafness. Air conduction thresholds with a pure tone average PTA4 of ≤ 20 dB (decibel) HL (Hearing Level) (mean of 0.5, 1, 2 and 3 kHz) in the good ear.
- Optimally fitted with Osia Sound processor, according to subject's experience prior to inclusion.
Who cannot join
- Any ongoing soft tissue complication that could significantly affect the use of the Osia 2 Sound Processor during the 6 weeks period
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
- Unable to follow investigational procedures and instructions, e.g. inability to complete quality of life scales or audiological testing as described in the Clinical Investigation Plan (CIP).
- Participation in another clinical investigation with pharmaceutical and/or device.
Trial locations and contacts
1 site in 1 country.
Australia1 site
HEARing CRC550 Swanston Street, Carlton
Melbourne, Victoria, 3053
About this study
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).
- Being tested
- Investigational device - Sound Processor
- Medical subject headings
- Deafness, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational device - Sound ProcessorDevice
At visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device - Sound Processor | Experimental | Not described Receives: Device: Investigational device - Sound Processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment.
Measured: Day 0 (Visit 1) and after 6 weeks (Visit 3)
Speech, Spatial, and Qualities of Hearing Scale (SSQ)
Measuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 (Visit 1) and with Investigational device after 6 weeks (Visit 3) with a questionnaire. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly" is used. An increase of a SSQ value reflects an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement and a negative value an impairment.
Measured: Day 0 and after 6 weeks
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Measuring QUEST (Self-reported assessment regarding satisfaction and usability) using a questionnaire, with the precursor sound processor at Day 0 (Visit 1) and with the Investigational device after 6 weeks (Visit 3). The QUEST form displays the scoring of 8 satisfaction items. The satisfaction items related to the characteristics of the device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness. A scale from 1 to 5, where 1 represent not satisfied at all, 2 not very satisfied, 3 more or less satisfied, 4 quiet satisfied and 5 represents very satisfied.
The three most important items of 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness were listed by each participant.
Measured: Day 0 and after 6 weeks
Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)
To measure threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) with both the precursor sound processor and the Investigational device. The units reported for PTA4 are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Measured: Baseline at visit 1, 6 weeks after study start at visit 3
Audiometric Thresholds in Freefield, Individual Frequencies
To measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursor sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Measured: 6 weeks after study start
Adaptive Speech Recognition in Noise Ratio
To measure Adaptive speech recognition in noise with the precursor sound processor and the Investigational device. Measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech and noise presented from the front (0 degrees azimuth). The speech is kept constant at 65 dB Sound Pressure Level (SPL) and the noise is adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.
Measured: Baseline at visit 1, 6 weeks after study start at visit 3
Speech in Quiet
To measure Speech in quiet at 50, 65 and 80 dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet environment at three different presentations levels, 50, 65 and 80 dB (decibel). The number of correct words perceived at each presentation level are counted and the percentage in relation to the total presented amount of words is calculated. A higher score reflects a higher percentage of correct words perceived, i.e. better hearing in a quiet environment.
Measured: Baseline at visit 1, 6 weeks after study start at visit 3
To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
The test subject will be asked a question regarding preferred choice made by selection between Investigational device and the precursor sound processor (comparator). Three boxes can be ticked; Precursor Sound Processor, Investigational Device, No preference.
Measured: 6 weeks after study start
To Assess the Subject's Experience Regarding Comfort
Measure Comfort by a visual analogue scale (VAS) 100 mm at Day 0 regarding the precursor sound processor and after 6 weeks regarding the Investigational device. Subject will be asked to put a line where they find most appropriate where 0 mm represents Not comfortable at all and 100 represents Most comfortable imaginable. The distance will be measured with a ruler and presented as a value between 0 and 100. A higher score reflects higher comfort.
Measured: Baseline at visit 1, 6 weeks after study start at visit 3
To Assess the Subject's Experience Regarding Usage; Magnet Choice
Magnet choice will be entered; four boxes are available, 1, 2, 3 and 4, the box with the strength chosen by the patient will be ticked. Magnet strength 1 is the weakest and 4 is the strongest.
Measured: 6 weeks after study start
To Assess the Subject's Experience Regarding Usage; Battery Life Time
The patient will be asked a question regarding battery life; "How often was the battery changed". A free text field is available for answer.
Measured: 6 weeks after study start
To Assess the Subject's Experience Regarding Usage; Softwear Pad
The patient will be asked a question "Did you use a SoftWear Pad in the last 6 weeks". The patient can tick a "Yes" or "No" box.
Measured: 6 weeks after study start
To Assess the Subject's Experience Regarding Usage; Safety Line
The patient will be asked a question "Did you use a safety line in the last 6 weeks". The patient can tick a "Yes" or "No" box.
Measured: 6 weeks after study start
To Assess the Subject's Experience Regarding Usage; Wireless Accessories
The patient will be asked a question "Did you use a Wireless accessory during the last 6 weeks". The patient can tick a "Yes" or "No" box.
Measured: 6 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start19 Feb 2019
- Primary completion23 Apr 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deafness; Sensoneural Single SidedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Cowan, Prof, Principal investigator, HEARing CRC550, Carlton, Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848910
- Sponsor's protocol ID
- CBAS5731
- Status last verified
- Jan 2020
- First submitted
- 8 Feb 2019
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
- ClinicalTrials.gov ID
- NCT03848910
- Acronym / sponsor ID
- CBAS5731
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the Investigational device and its precursor Sound Processor (Comparator) after 6 weeks in subjects with conductive/mixed hearing loss or Single Sided Deafness, (SSD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational device - Sound Processor | Experimental | Device: Investigational device - Sound Processor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed clinical investigation CBAS5539, and an active user of the Osia System.
- Signed Informed consent.
- Subject with conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB HL.
- OR subject with single-sided sensorineural deafness. Air conduction thresholds with a pure tone average PTA4 of ≤ 20 dB (decibel) HL (Hearing Level) (mean of 0.5, 1, 2 and 3 kHz) in the good ear.
- Optimally fitted with Osia Sound processor, according to subject's experience prior to inclusion.
Key exclusion criteria (4 listed)
- Any ongoing soft tissue complication that could significantly affect the use of the Osia 2 Sound Processor during the 6 weeks period
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
- Unable to follow investigational procedures and instructions, e.g. inability to complete quality of life scales or audiological testing as described in the Clinical Investigation Plan (CIP).
- Participation in another clinical investigation with pharmaceutical and/or device.
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 |
|---|---|---|
| Investigational device - Sound ProcessorAt visit 1 the subjects will complete self-reported assessments with respect to "pre-study experience" using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator. | Device | Investigational device - Sound Processor |
Primary outcome
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Day 0 (Visit 1) and after 6 weeks (Visit 3)
Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment.
Speech, Spatial, and Qualities of Hearing Scale (SSQ)
Time frame: Day 0 and after 6 weeks
Measuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 (Visit 1) and with Investigational device after 6 weeks (Visit 3) with a questionnaire. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly" is used. An increase of a SSQ value reflects an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement and a negative value an impairment.
Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
Time frame: Day 0 and after 6 weeks
Measuring QUEST (Self-reported assessment regarding satisfaction and usability) using a questionnaire, with the precursor sound processor at Day 0 (Visit 1) and with the Investigational device after 6 weeks (Visit 3). The QUEST form displays the scoring of 8 satisfaction items. The satisfaction items related to the characteristics of the device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness. A scale from 1 to 5, where 1 represent not satisfied at all, 2 not very satisfied, 3 more or less satisfied, 4 quiet satisfied and 5 represents very satisfied. The three most important items of 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness were listed by each participant.
Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)
Time frame: Baseline at visit 1, 6 weeks after study start at visit 3
To measure threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) with both the precursor sound processor and the Investigational device. The units reported for PTA4 are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Audiometric Thresholds in Freefield, Individual Frequencies
Time frame: 6 weeks after study start
To measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursor sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Adaptive Speech Recognition in Noise Ratio
Time frame: Baseline at visit 1, 6 weeks after study start at visit 3
To measure Adaptive speech recognition in noise with the precursor sound processor and the Investigational device. Measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech and noise presented from the front (0 degrees azimuth). The speech is kept constant at 65 dB Sound Pressure Level (SPL) and the noise is adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.
Speech in Quiet
Time frame: Baseline at visit 1, 6 weeks after study start at visit 3
To measure Speech in quiet at 50, 65 and 80 dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet environment at three different presentations levels, 50, 65 and 80 dB (decibel). The number of correct words perceived at each presentation level are counted and the percentage in relation to the total presented amount of words is calculated. A higher score reflects a higher percentage of correct words perceived, i.e. better hearing in a quiet environment.
To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
Time frame: 6 weeks after study start
The test subject will be asked a question regarding preferred choice made by selection between Investigational device and the precursor sound processor (comparator). Three boxes can be ticked; Precursor Sound Processor, Investigational Device, No preference.
To Assess the Subject's Experience Regarding Comfort
Time frame: Baseline at visit 1, 6 weeks after study start at visit 3
Measure Comfort by a visual analogue scale (VAS) 100 mm at Day 0 regarding the precursor sound processor and after 6 weeks regarding the Investigational device. Subject will be asked to put a line where they find most appropriate where 0 mm represents Not comfortable at all and 100 represents Most comfortable imaginable. The distance will be measured with a ruler and presented as a value between 0 and 100. A higher score reflects higher comfort.
To Assess the Subject's Experience Regarding Usage; Magnet Choice
Time frame: 6 weeks after study start
Magnet choice will be entered; four boxes are available, 1, 2, 3 and 4, the box with the strength chosen by the patient will be ticked. Magnet strength 1 is the weakest and 4 is the strongest.
To Assess the Subject's Experience Regarding Usage; Battery Life Time
Time frame: 6 weeks after study start
The patient will be asked a question regarding battery life; "How often was the battery changed". A free text field is available for answer.
To Assess the Subject's Experience Regarding Usage; Softwear Pad
Time frame: 6 weeks after study start
The patient will be asked a question "Did you use a SoftWear Pad in the last 6 weeks". The patient can tick a "Yes" or "No" box.
To Assess the Subject's Experience Regarding Usage; Safety Line
Time frame: 6 weeks after study start
The patient will be asked a question "Did you use a safety line in the last 6 weeks". The patient can tick a "Yes" or "No" box.
To Assess the Subject's Experience Regarding Usage; Wireless Accessories
Time frame: 6 weeks after study start
The patient will be asked a question "Did you use a Wireless accessory during the last 6 weeks". The patient can tick a "Yes" or "No" box.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Robert Cowan, Prof principal investigator
HEARing CRC550, Carlton, Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device - Sound Processor in people with Deafness; Sensoneural Single Sided and Conductive Hearing Loss, run by Cochlear at 1 site in Australia.
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 5 inclusion and 4 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 14 Oct 2021. 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 Australia. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: Day 0 (Visit 1) and after 6 weeks (Visit 3)). The study lists 14 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 14 Oct 2021.