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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03848910
Registration number
NCT03848910
Ethics application status
Date submitted
8/02/2019
Date registered
21/02/2019
Titles & IDs
Public title
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
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Scientific title
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
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Secondary ID [1]
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CBAS5731
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Deafness; Sensoneural Single Sided
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Conductive Hearing Loss
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Mixed Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Investigational device - Sound Processor
Experimental: Investigational device - Sound Processor -
Treatment: Devices: Investigational device - Sound Processor
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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
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Assessment method [1]
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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.
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Timepoint [1]
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Day 0 (Visit 1) and after 6 weeks (Visit 3)
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Primary outcome [2]
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Speech, Spatial, and Qualities of Hearing Scale (SSQ)
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Assessment method [2]
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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.
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Timepoint [2]
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Day 0 and after 6 weeks
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Primary outcome [3]
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Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)
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Assessment method [3]
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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.
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Timepoint [3]
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Day 0 and after 6 weeks
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Primary outcome [4]
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Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline at visit 1, 6 weeks after study start at visit 3
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Primary outcome [5]
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Audiometric Thresholds in Freefield, Individual Frequencies
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Assessment method [5]
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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.
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Timepoint [5]
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6 weeks after study start
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Primary outcome [6]
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Adaptive Speech Recognition in Noise Ratio
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline at visit 1, 6 weeks after study start at visit 3
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Primary outcome [7]
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Speech in Quiet
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline at visit 1, 6 weeks after study start at visit 3
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Primary outcome [8]
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To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
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Assessment method [8]
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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.
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Timepoint [8]
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6 weeks after study start
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Primary outcome [9]
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To Assess the Subject's Experience Regarding Comfort
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline at visit 1, 6 weeks after study start at visit 3
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Primary outcome [10]
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To Assess the Subject's Experience Regarding Usage; Magnet Choice
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Assessment method [10]
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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.
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Timepoint [10]
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6 weeks after study start
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Primary outcome [11]
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To Assess the Subject's Experience Regarding Usage; Battery Life Time
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Assessment method [11]
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The patient will be asked a question regarding battery life; "How often was the battery changed". A free text field is available for answer.
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Timepoint [11]
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6 weeks after study start
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Primary outcome [12]
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To Assess the Subject's Experience Regarding Usage; Softwear Pad
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Assessment method [12]
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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.
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Timepoint [12]
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6 weeks after study start
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Primary outcome [13]
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To Assess the Subject's Experience Regarding Usage; Safety Line
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Assessment method [13]
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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.
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Timepoint [13]
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6 weeks after study start
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Primary outcome [14]
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To Assess the Subject's Experience Regarding Usage; Wireless Accessories
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Assessment method [14]
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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.
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Timepoint [14]
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6 weeks after study start
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Eligibility
Key inclusion criteria
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/04/2019
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Sample size
Target
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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HEARing CRC550 Swanston Street, Carlton - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cochlear
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/study/NCT03848910
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert Cowan, Prof
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Address
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HEARing CRC550, Carlton, Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/10/NCT03848910/Prot_001.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/10/NCT03848910/SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03848910