Home Test of New Sound Processor

NCT04559282 | Completed Results

• 1 other identifier: CBAS5779
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Conductive Hearing Loss; Mixed Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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 Adaptive Speech Test in Noise

  Day 0 and day 7

• Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry

  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 the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating

  Day 14

Study Arms (2)

New SP followed by Baha 5 SP followed by single blinded SP

EXPERIMENTAL

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

Baha 5 SP followed by the New SP followed by single blinded SP

EXPERIMENTAL

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

Interventions

New Sound Processor DEVICE

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.

Baha 5 SP followed by the New SP followed by single blinded SP; New SP followed by Baha 5 SP followed by single blinded SP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead
• Statistiska Konsultgruppen: collaborator

Study Sites (1)

Cochlear Bone Anchored Solutions AB (CBAS)

Mölnlycke, SE-435 33, Sweden

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therese Agat
• Organization: Cochlear

tagat@cochlear.com

+46766498562

Study Officials

• Karin Ganlöv, MD

  Cochlear

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: September 23, 2020
• Primary Completion: November 27, 2020
• Study Completion: November 27, 2020
• Last Updated: November 22, 2021
• Results First Posted: November 22, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)