Home Test of New Sound Processor

Study Overview
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Brief Summary
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The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.

Official Title
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A Pivotal, Prospective, Single-centre, Randomized Test Order, Crossover, Open Label Study Comparing the Performance of a New Sound Processor With Unaided Hearing and Baha 5 in Adult Subjects With Conductive or Mixed Hearing Loss

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: New Sound Processor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subject (18-<70 years of age) At least 12 months experience from using a Baha Connect system (percutaneous Baha) Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist Willing and able to provide written informed consent Exclusion Criteria: Signs of infection around the implant site Unable to follow investigational procedures Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New SP followed by Baha 5 SP followed by single blinded SP<br>Aided hearing with new Sound Processor followed by aided hearing with the Baha 5 sound processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing). | Device: New Sound Processor<br>* The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.<br>|
| Experimental: Baha 5 SP followed by the New SP followed by single blinded SP<br>Aided hearing with Baha 5 sound processor followed by aided hearing with the new Sound Processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing). | Device: New Sound Processor<br>* The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise | Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding | Day 0, day 7 and day 14 | 
| Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor. | Day 7 and day 14 | 
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise | Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding | Day 0 and day 7 | 
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz] | Day 0 and day 7 | 
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words. | Day 0 and day 7 | 
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips. | Day 14 | 
| Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Participant rating Yes or No for internal noise after listening to sound clips. | Day 14 | 
| Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort. | Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort. | Day 14 | 
| Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz] | Day 0, day 7 and day 14 | 
| Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words | Day 0, day 7 and day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conductive Hearing Loss, Mixed Hearing Loss