Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
Conditions
Brief 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.
Interventions
DEVICECochlear Osia 3 Sound Processor
Osia 3 Sound Processor including sound processor magnets and Osia 3 Aqua +
DEVICECochlear™ Osia® 2 Sound Processor
Osia® 2 Sound Processor and Osia 2 Aqua +
Sponsors
Cochlear
Avania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Within-subject
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * For voluntary visit Aqua+ in water only: Be comfortable with going into a swimming pool and putting head under water.
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL | During week 48-52 | 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. |
| 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 | During week 48-52 | 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. |
| Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips | During week 48-52 | 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. |
| Change (within subject) in the subjective rating of different aspects of sound during a walk | During week 48-52 | 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. |
| Percentage of participants who preferred Osia 3 over Osia 2 sound processor | During week 48-52 | Participants will be asked which device they prefer after having listened with both devices (Osia 2 and Osia 3) to different sound clips. |
Countries
Australia
Contacts
STUDY_DIRECTORTherese Agat
Cochlear
Outcome results
None listed