Home Test of New Sound Processor

Not Applicable

Completed

Conditions: Hearing Loss

Interventions: Device: New Sound Processor

Registration Number: NCT04559282

Lead Sponsor: Cochlear

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Baha 5 SP followed by the New SP followed by single blinded SP	New Sound Processor	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).
New SP followed by Baha 5 SP followed by single blinded SP	New Sound Processor	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).

Primary Outcome Measures

Name	Time	Method
Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise	Day 0, day 7 and day 14	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
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF	Day 14

Secondary Outcome Measures

Name	Time	Method
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry	Day 0 and day 7	Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz\]
Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet	Day 0, day 7 and day 14	Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary	Day 7 and day 14	Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor.
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating	Day 14	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.
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise	Day 0 and day 7	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
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet	Day 0 and day 7	Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words.
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry	Day 0, day 7 and day 14	Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz\]
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise	Day 14	Participant rating Yes or No for internal noise after listening to sound clips.
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.	Day 14	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.