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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear™ Osia® System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Osia 3 Sound Processor | Device | Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua + |
|
| 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 48-52 |
| 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 48-52 |
| 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 48-52 |
| Change (within subject) in the subjective rating of different aspects of sound during a walk | The investigator will hold a conversation with the participant in real-life situations while they wear the Osia 3 sound processor (sound processor only or combined with Osia 3 Aqua+) or Osia 2 sound processor. After the walk, the investigator will ask the participant to rate specific aspects of the sound they experienced on a Likert scale from 1 to 5. | During week 48-52 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Therese Agat | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The HEARing CRC | Melbourne | Victoria | 3053 | Australia |
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.
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Within-subject
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| Cochlear™ Osia® 2 Sound Processor | Device | Osia® 2 Sound Processor and Osia 2 Aqua + |
|
| 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 48-52 |
| ID | Term |
|---|---|
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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