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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06338670
Registration number
NCT06338670
Ethics application status
Date submitted
24/03/2024
Date registered
29/03/2024
Titles & IDs
Public title
Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users
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Scientific title
A Pre-market, Feasibility, Prospective, Open-label, Within Subject Investigation Evaluating the Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Recipients
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Secondary ID [1]
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CLTD5839
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Universal Trial Number (UTN)
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Trial acronym
RECONNECT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Mixed Conductive-Sensorineural
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Hearing Loss, Conductive
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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 - Cochlear Osia 3 Sound Processor
Treatment: Devices - Cochlear™ Osia® 2 Sound Processor
Experimental: Cochlear™ Osia® System - Participants will receive the Osia 3 and Osia® 2 sound processors. They will then complete a series of assessments designed to evaluate the clinical performance of these two sound processors. These assessments will take place across four study visits.
Treatment: Devices: Cochlear Osia 3 Sound Processor
Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua +
Treatment: Devices: Cochlear™ Osia® 2 Sound Processor
Osia® 2 Sound Processor
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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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Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL
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Assessment method [1]
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Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The AuSTIN corpus comprises 80 lists of 20 sentences each, recorded in female voice. The goal of the adaptive Speech-in-Noise test is to obtain the Speech Reception Threshold in noise.
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Timepoint [1]
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During week 24-26
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Primary outcome [2]
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Change (within subject) in word recognition score in quiet measured at 65 dB SPL
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Assessment method [2]
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Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 65 dB SPL from the front speaker. The goal of speech perception assessment in quiet is to obtain the percentage of correctly repeated words in a list, i.e., the word recognition score.
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Timepoint [2]
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During week 24-26
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Primary outcome [3]
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Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz
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Assessment method [3]
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Aided thresholds in sound field will be measured using warble tones presented from a front speaker positioned at 1 m from the subject following the modified Hughson-Westlake procedure. Frequencies to be tested are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz.
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Timepoint [3]
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During week 24-26
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Primary outcome [4]
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Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips
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Assessment method [4]
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After listening to different sound clips with Osia 3 and the Osia 2 sound processors, the subjects will rate specific aspects of the sound, e.g., loudness or sound quality, on a Likert scale from 1 to 5 in steps of 1. A rating of 1 is least positive while a rating of 5 is most positive. They will also be asked to explain their sound quality experience in their own words per sound clip.
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Timepoint [4]
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During week 24-26
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Primary outcome [5]
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Percentage of participants who preferred Osia 3 over Osia 2 sound processor
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Assessment method [5]
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Participants will be asked which device they prefer after having listened with both devices (Osia 2 and Osia 3) to different sound clips.
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Timepoint [5]
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During week 24-26
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Eligibility
Key inclusion criteria
* Implanted with a Cochlear Osia Implant (OSI100 or OSI200)
* Conductive or mixed hearing loss in the implanted ear. Bone conduction threshold 4-frequency pure tone average (PTA4; mean of bone conduction thresholds at 0.5, 1, 2 and 4 kHz) = 55 dB HL.
OR Single-Sided Deafness in the implanted ear. Air Conduction threshold 4-frequency pure tone average (PTA4; mean of air conduction thresholds at 0.5, 1, 2 and 3 kHz) = 20 dB HL in the good ear.
* Aged 18 years or older, at time of consent.
* Minimum experience of 1 month with the Osia 2 Sound Processor.
* Fluent speaker in the language used to assess speech perception performance.
* Willing and able to provide written informed consent.
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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
* Sensitivity to loud sounds.
* Ongoing infection at or around the sound processor area.
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
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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
Recruiting
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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
5/07/2024
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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
1/02/2025
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The HEARing CRC - 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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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Avania
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors.
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Trial website
https://clinicaltrials.gov/study/NCT06338670
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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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Therese Agat
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Address
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Cochlear
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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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Therese Agat
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Address
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Country
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Phone
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+46766498562
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Fax
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Email
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[email protected]
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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
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06338670