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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
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)
Timepoint [1] 0 0
Day 0 (Visit 1) and after 6 weeks (Visit 3)
Primary outcome [2] 0 0
Speech, Spatial, and Qualities of Hearing Scale (SSQ)
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)
Timepoint [3] 0 0
Day 0 and after 6 weeks
Primary outcome [4] 0 0
Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)
Timepoint [4] 0 0
Baseline at visit 1, 6 weeks after study start at visit 3
Primary outcome [5] 0 0
Audiometric Thresholds in Freefield, Individual Frequencies
Timepoint [5] 0 0
6 weeks after study start
Primary outcome [6] 0 0
Adaptive Speech Recognition in Noise Ratio
Timepoint [6] 0 0
Baseline at visit 1, 6 weeks after study start at visit 3
Primary outcome [7] 0 0
Speech in Quiet
Timepoint [7] 0 0
Baseline at visit 1, 6 weeks after study start at visit 3
Primary outcome [8] 0 0
To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor
Timepoint [8] 0 0
6 weeks after study start
Primary outcome [9] 0 0
To Assess the Subject's Experience Regarding Comfort
Timepoint [9] 0 0
Baseline at visit 1, 6 weeks after study start at visit 3
Primary outcome [10] 0 0
To Assess the Subject's Experience Regarding Usage; Magnet Choice
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
Timepoint [11] 0 0
6 weeks after study start
Primary outcome [12] 0 0
To Assess the Subject's Experience Regarding Usage; Softwear Pad
Timepoint [12] 0 0
6 weeks after study start
Primary outcome [13] 0 0
To Assess the Subject's Experience Regarding Usage; Safety Line
Timepoint [13] 0 0
6 weeks after study start
Primary outcome [14] 0 0
To Assess the Subject's Experience Regarding Usage; Wireless Accessories
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 (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.
Minimum age
18 Years
Maximum age
No limit
Sex
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 the Clinical Investigation Plan (CIP).
* Participation in another clinical investigation with pharmaceutical and/or device.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
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
19/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/04/2019
Sample size
Target
Accrual to date
Final
11
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03848910