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

Cochlear1 site in 1 country16 target enrollmentSeptember 23, 2020

ConditionsHearing Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss
Sponsor: Cochlear
Enrollment: 16
Locations: 1
Primary Endpoint: Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 23, 2020

End Date

November 27, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise

Time Frame: 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

Time Frame: Day 14

Secondary Outcomes

Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry(Day 0 and day 7)
Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet(Day 0, day 7 and day 14)
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)
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating(Day 14)
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise(Day 0 and day 7)
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet(Day 0 and day 7)
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry(Day 0, day 7 and day 14)
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise(Day 14)
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.(Day 14)