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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
Date last updated
12/11/2024

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 - Cochlearâ„¢ Osia® 2 Sound Processor

Experimental: Cochlearâ„¢ 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: Cochlearâ„¢ 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
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
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
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.
Trial website
https://clinicaltrials.gov/study/NCT06338670
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
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06338670