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Completed

NCT Number: NCT04559282

Home Test of New Sound Processor

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Bone Anchored Solutions AB (CBAS)

Mölnlycke, SE-435 33, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF

    Time frame: Day 14

Secondary outcomes

  1. Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary

    Time frame: Day 7 and day 14

    Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor.

  2. Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise

    Time frame: Day 0 and day 7

    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

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

    Time frame: Day 0 and day 7

    Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz]

  4. Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet

    Time frame: Day 0 and day 7

    Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words.

  5. Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating

    Time frame: Day 14

    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.

  6. Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise

    Time frame: Day 14

    Participant rating Yes or No for internal noise after listening to sound clips.

  7. Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.

    Time frame: Day 14

    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.

  8. Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry

    Time frame: Day 0, day 7 and day 14

    Sound-field [0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz]

  9. Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet

    Time frame: Day 0, day 7 and day 14

    Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Statistiska Konsultgruppen

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 22, 2020
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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