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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03848910




Registration number
NCT03848910
Ethics application status
Date submitted
8/02/2019
Date registered
21/02/2019
Date last updated
19/06/2019

Titles & IDs
Public title
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
Scientific title
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor
Secondary ID [1] 0 0
CBAS5731
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deafness; Sensoneural Single Sided 0 0
Conductive Hearing Loss 0 0
Mixed Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Abbreviated Profile of Hearing Aid Benefit (APHAB) - Measuring 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. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem.
Timepoint [1] 0 0
Day 0 and after 6 weeks
Primary outcome [2] 0 0
Speech, Spatial, and Qualities of Hearing Scale (SSQ) - Measuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 and with Investigational device after 6 wseeks. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly" is used.
Timepoint [2] 0 0
Day 0 and after 6 weeks
Primary outcome [3] 0 0
Self-reported assessment regarding satisfaction and usability (QUEST version 2) - Measuring QUESTwith the precursor sound processor at Day 0 and with the Investigational device after 6 weeks. The QUEST form displays the scoring of 8 satisfation 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 0 to 10, where 0 represent not at all and 10 represents perfectly.
Timepoint [3] 0 0
Day 0 and after 6 weeks
Primary outcome [4] 0 0
Audiometric thresholf 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). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Timepoint [4] 0 0
6 weeks after study start
Primary outcome [5] 0 0
Audiometric thresholf in freefield, individual frequencies - To measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursou sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Timepoint [5] 0 0
6 weeks after study start
Primary outcome [6] 0 0
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 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.
Timepoint [6] 0 0
6 weeks after study start
Primary outcome [7] 0 0
Speech in Quiet - To measure Speech in quiet at 50, 65 and 80dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet enviroment 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 perecived, i.e. better hearing in a quiet enviroment.
Timepoint [7] 0 0
6 weeks after study start
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
6 weeks after study start
Primary outcome [9] 0 0
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 comfortble 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.
Timepoint [9] 0 0
6 weeks after study start
Primary outcome [10] 0 0
To assess the subject's experience regarding Usage; Magnet chioice - 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 weekest and 4 is the strongest.
Timepoint [10] 0 0
6 weeks after study start
Primary outcome [11] 0 0
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.
Timepoint [11] 0 0
6 weeks after study start
Primary outcome [12] 0 0
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.
Timepoint [12] 0 0
6 weeks after study start
Primary outcome [13] 0 0
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.
Timepoint [13] 0 0
6 weeks after study start
Primary outcome [14] 0 0
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.
Timepoint [14] 0 0
6 weeks after study start

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 HL (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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 this CIP.

- Participation in another clinical investigation with pharmaceutical and/or device.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
HEARing CRC550 Swanston Street, Carlton - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Bone Anchored Solutions
Address
Country

Ethics approval
Ethics application status

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 SSD.
Trial website
https://clinicaltrials.gov/show/NCT03848910
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Cowan, Prof
Address 0 0
HEARing CRC550, Carlton, Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications