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

Hearing Loss, Conductive Clinical Trial

— RECONNECT  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338670
• Other study ID #: CLTD5839
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Cochlear
• Contact: Therese Agat
• Phone: +46766498562
• Email: tagat[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural

Intervention

Device:
• Cochlear Osia 3 Sound Processor
Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua +
• Cochlear™ Osia® 2 Sound Processor
Osia® 2 Sound Processor

Locations

Country	Name	City	State
Australia	The HEARing CRC	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	Avania

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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