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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
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
Secondary ID [1] 0 0
CLTD5839
Universal Trial Number (UTN)
Trial acronym
RECONNECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Mixed Conductive-Sensorineural 0 0
Hearing Loss, Conductive 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 - 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL
Timepoint [1] 0 0
During week 24-26
Primary outcome [2] 0 0
Change (within subject) in word recognition score in quiet measured at 65 dB SPL
Timepoint [2] 0 0
During week 24-26
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
During week 24-26
Primary outcome [4] 0 0
Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips
Timepoint [4] 0 0
During week 24-26
Primary outcome [5] 0 0
Percentage of participants who preferred Osia 3 over Osia 2 sound processor
Timepoint [5] 0 0
During week 24-26

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The HEARing CRC - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Therese Agat
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Therese Agat
Address 0 0
Country 0 0
Phone 0 0
+46766498562
Fax 0 0
Email 0 0
tagat@cochlear.com
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
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.


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