Home Test of New Sound Processor

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559282
• Other study ID #: CBAS5779
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: November 27, 2020

Study information

• Verified date: December 2020
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 27, 2020
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Sweden	Cochlear Bone Anchored Solutions AB (CBAS)	Mölnlycke

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	Statistiska Konsultgruppen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF		Day 14
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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