Home Test of New Sound Processor

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: New Sound Processor

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Mölnlycke, Sweden, SE-435 33
    • Cochlear Bone Anchored Solutions AB (CBAS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New SP followed by Baha 5 SP followed by single blinded SP; 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; 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.
Experimental: Baha 5 SP followed by the New SP followed by single blinded SP; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Statistiska Konsultgruppen
• Investigators: Study Director: Karin Ganlöv, MD, Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): November 27, 2020
• Study Completion (Actual): November 27, 2020

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Conductive Hearing Loss; Mixed Hearing Loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: CBAS5779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No