Clinical trial NCT04559282: Home Test of New Sound Processor
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Conductive Hearing Loss
Mixed Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Statistiska Konsultgruppen
First posted: 2020-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
timeFrame: Day 0, day 7 and day 14
measure: Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
timeFrame: Day 14
Secondary outcomes:
measure: Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
timeFrame: Day 7 and day 14
measure: Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
timeFrame: Day 0 and day 7
measure: Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
timeFrame: Day 0 and day 7
measure: Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
timeFrame: Day 0 and day 7
measure: Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
timeFrame: Day 14
measure: Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
timeFrame: Day 14
measure: Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
timeFrame: Day 14
measure: Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
timeFrame: Day 0, day 7 and day 14
measure: Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet
timeFrame: Day 0, day 7 and day 14
Other outcomes:
Locations:
city: Mölnlycke
country: Sweden
facility: Cochlear Bone Anchored Solutions AB (CBAS)
Study officials:
affiliation: Cochlear
name: Karin Ganlöv, MD
role: STUDY_DIRECTOR
References: