Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients

NCT07156461 | Completed FDA Device

• 1 other identifier: CLTD5861
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 3

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

Conditions

Single-Sided Deafness; Bone Conduction; Hearing Loss, Mixed; Hearing Loss, Conductive

Keywords

Bone Conduction

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)

Secondary Outcomes (9)

• 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

  At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)

• 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

  At Baseline (Day 0), Visit 1 (7-14 days after Baseline), and Visit 2 (7-14 days after Visit 1)

• 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

  At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)

• 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

  At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)

• 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

  At Visit 1 (7-14 days after Baseline) and Visit 2 (7-14 days after Visit 1)

Study Arms (2)

Cochlear™ Osia® 2 Sound Processor

ACTIVE COMPARATOR

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.

Device: Cochlear™ Osia® System (Osia® 2); Device: Cochlear™ Osia® System (Osia® 3)

Cochlear™ Osia® 3 Sound Processor

EXPERIMENTAL

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.

Device: Cochlear™ Osia® System (Osia® 2); Device: Cochlear™ Osia® System (Osia® 3)

Interventions

Cochlear™ Osia® System (Osia® 2) DEVICE

Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2.

Cochlear™ Osia® 2 Sound Processor; Cochlear™ Osia® 3 Sound Processor

Cochlear™ Osia® System (Osia® 3) DEVICE

Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3.

Cochlear™ Osia® 2 Sound Processor; Cochlear™ Osia® 3 Sound Processor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cochlear: lead
• Avania: collaborator

Study Sites (3)

Cochlear Americas, Denver Research and Technology Lab

Denver, Colorado, 80124, United States

Location

Cochlear Macquarie, Macquarie University

Sydney, New South Wales, 2109, Australia

Location

HEARnet Clinical Studies

Melbourne, Victoria, 3010, Australia

Location

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• PRS Specialist

  Cochlear Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation uses a repeated-measures, cross-over design where study recipients will be randomized into one of two groups (1:1 ratio)

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 5, 2025
• Study Start: September 9, 2025
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (2)