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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07156461
Registration number
NCT07156461
Ethics application status
Date submitted
26/08/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Titles & IDs
Public title
Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients
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Scientific title
A Pivotal, Interventional, Prospective, Multi-centre Clinical Investigation of Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients With Mixed Hearing Loss, Conductive Hearing Loss or Single-Sided Deafness
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Secondary ID [1]
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CLTD5861
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Universal Trial Number (UTN)
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Trial acronym
SONUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Mixed
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Hearing Loss, Conductive
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Single-Sided Deafness
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Bone Conduction
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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® System (Osia® 2)
Treatment: Devices - Cochlear™ Osia® System (Osia® 3)
Active comparator: Cochlear™ Osia® 2 Sound Processor - Participants randomized to group 1 will first receive a study Osia 2 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 3 Sound Processor and complete the same protocol.
Experimental: Cochlear™ Osia® 3 Sound Processor - Participants randomized to group 2 will first receive a Osia 3 Sound Processor to use at home for 1-2 weeks, before returning to the clinic to complete various assessments. These participants will then switch to the Osia 2 Sound Processor and complete the same protocol.
Treatment: Devices: Cochlear™ Osia® System (Osia® 2)
Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2.
Treatment: Devices: Cochlear™ Osia® System (Osia® 3)
Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3.
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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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Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline
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Assessment method [1]
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Speech perception in noise will be assessed using the Australian Speech Test in Noise (AuSTIN) at the Australian sites and the Bamford-Kowal-Bench Speech-In-Noise (BKB-SIN) test at the US site. The AuSTIN uses BKB-SIN like target sentences presented in noise and comprises of 80 lists of 20 sentences each. The BKB-SIN test contains 18 list pairs of sentences, each containing 3-4 key words, presented at 65 dB SPL with adaptive noise levels. Both tests aim to determine the signal-to-noise ratio (SNR) at which 50% of the key words are correctly repeated. For the unaided and aided measurements, speech performance in noise will be measured with speech and noise presented from a front speaker, positioned at 1 m from the subject.
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Timepoint [1]
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At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [1]
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Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting compared to the unaided condition at baseline
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Assessment method [1]
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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 CNC word test consists of 30 lists each with 50 words per list. The goal of the 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 [1]
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At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [2]
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Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor, 1-2 weeks after fitting compared to the unaided condition at baseline
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Assessment method [2]
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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 [2]
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At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [3]
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Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of 0 dB SNR, 1-2 weeks after fitting
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Assessment method [3]
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Speech perception in noise with a fixed SNR will be measured using the AzBio sentence test, which consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. The sentences will be presented at a fixed level of 65 dB SPL at a fixed SNR of 0 dB SNR using the accompanying noise stimulus. Each word in the sentence counts towards the overall score (percent correct). Speech will be presented from the front, while noise will be presented from the rear.
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Timepoint [3]
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At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [4]
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Mean difference in speech perception in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at a fixed signal-to-noise ratio (SNR) of +5 dB SNR, 1-2 weeks after fitting
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Assessment method [4]
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Speech perception in noise with a fixed SNR will be measured using the AzBio sentence test, which consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. The sentences will be presented at a fixed level of 65 dB SPL at a fixed SNR of +5 dB SNR using the accompanying noise stimulus. Each word in the sentence counts towards the overall score (percent correct). Speech will be presented from the front, while noise will be presented from the rear.
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Timepoint [4]
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At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [5]
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Mean difference in the Speech Spatial and Qualities of Hearing Scale (SSQ-12) global score with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting
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Assessment method [5]
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The SSQ-12 involves a self-reported hearing function and the impact of hearing treatment in daily life across a variety of listening situations. It includes 3 subcategories: Speech Hearing, Spatial Hearing, and Qualities of Hearing, with each question rated on a Likert scale from 0-10 (minimum - maximum hearing abilities).
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Timepoint [5]
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At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [6]
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Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 50 dB SPL, 1-2 weeks after fitting
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Assessment method [6]
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Speech perception in quiet will be measured using the consonant-nucleus-consonant (CNC) monosyllabic words presented at 50 dB SPL from the front speaker. The CNC word test consists of 30 lists each with 50 words per list. The goal of the 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 [6]
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At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [7]
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Mean difference in the word recognition score in quiet with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor measured at 65 dB SPL, 1-2 weeks after fitting
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Assessment method [7]
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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 CNC word test consists of 30 lists each with 50 words per list. The goal of the 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 [7]
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At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [8]
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Mean difference in speech reception threshold in noise with the Osia 3 Sound Processor compared with the Osia 2 Sound Processor, 1-2 weeks after fitting
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Assessment method [8]
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Speech perception in noise will be assessed using the Australian Speech Test in Noise (AuSTIN) at the Australian sites and the Bamford-Kowal-Bench-Speech in Noise (BKB-SIN) test at the US site. The AuSTIN uses BKB-SIN like target sentences presented in noise and comprises of 80 lists of 20 sentences each. The BKB-SIN test contains 18 list pairs of sentences, each containing 3-4 key words, presented at 65 dB SPL with adaptive noise levels. Both tests aim to determine the signal-to-noise ratio (SNR) at which 50% of the key words are correctly repeated. For the unaided and aided measurements, speech performance in noise will be measured with speech and noise presented from a front speaker, positioned at 1 m from the subject.
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Timepoint [8]
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At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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Secondary outcome [9]
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Mean difference in the four-frequency sound field threshold average (PTA4, mean of sound field thresholds at 0.5, 1, 2, and 4 kHz) with the Osia 3 Sound Processor compared to the Osia 2 Sound Processor, 1-2 weeks after fitting
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Assessment method [9]
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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 [9]
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At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)
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Eligibility
Key inclusion criteria
* Implanted with a Cochlear Osia Implant (OSI100, OSI200, OSI300)
* Conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds up to 65 dB HL (up to 40 dB HL at 0.5 kHz, up to 55 dB HL at 1kHz and up to 65 dB HL at 2 and 4 kHz) or Single-Sided Deafness in the implanted ear. The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and, 3 kHz).
* 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
* Ongoing infection at or around the sound processor area.
* Bilaterally implanted with a Cochlear Osia Implant.
* 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
Randomised controlled trial
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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
Crossover
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet 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
1/09/2025
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Actual
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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
1/12/2025
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Actual
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Sample size
Target
29
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Cochlear Macquarie, Macquarie University - Sydney
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Recruitment hospital [2]
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HEARnet Clinical Studies - Melbourne
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Recruitment postcode(s) [1]
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2109 - Sydney
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Recruitment postcode(s) [2]
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3010 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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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
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness. The main questions this study aims to answer are: * Do the findings confirm the clinical performance of the Osia 3 Sound Processor? * Is the Osia 3 Sound Processor superior compared to the Osia 2 Sound Processor? Participants will: * Undergo speech performance testing in both quiet and noisy environments * Provide ratings for a self-reported questionnaire
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Trial website
https://clinicaltrials.gov/study/NCT07156461
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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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PRS Specialist
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Address
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Cochlear Ltd
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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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PRS Specialist
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Address
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Country
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Phone
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+61 2 9428 6555
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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
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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/NCT07156461
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