Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users (RECONNECT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Intervention / Treatment: Device: Cochlear Osia 3 Sound Processor; Device: Cochlear™ Osia® 2 Sound Processor

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Therese Agat; Phone Number: +46766498562; Email: tagat@cochlear.com
• Study Contact Backup: Name: Christiane L D´hondt; Phone Number: +32487167531; Email: cdhondt@cochlear.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3053
      • The HEARing CRC
      • Contact: Robert Cowan; Phone Number: +61418780198; Email: r.cowan@unimelb.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Cochlear Osia 3 Sound Processor; Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua +; Device: Cochlear™ Osia® 2 Sound Processor; Osia® 2 Sound Processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL	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.	During week 24-26
Change (within subject) in word recognition score in quiet measured at 65 dB SPL	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.	During week 24-26
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	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.	During week 24-26
Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips	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.	During week 24-26
Percentage of participants who preferred Osia 3 over Osia 2 sound processor	Participants will be asked which device they prefer after having listened with both devices (Osia 2 and Osia 3) to different sound clips.	During week 24-26

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Avania
• Investigators: Study Director: Therese Agat, Cochlear

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2024
• Primary Completion (Estimated): November 22, 2024
• Study Completion (Estimated): November 22, 2024

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: March 24, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: CLTD5839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No