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OpenTrials
Completed

NCT Number: NCT03333577

Evaluation of the Baha SoundArc in Pediatric Patients

The purpose of this study is to gather clinical performance data on the Baha SoundArc

Completed

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Key information

Conditions

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

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Hearing and Balance, Chandler, Arizona, United States

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About this study

Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

• Existing recipients using a Baha sound processor on a Softband for at least three months

  • Subjects aged 5 through 12 years of age
  • Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)
  • Willingness on behalf of the subject's parent or guardian to complete study questionnaire

Exclusion criteria

• Subject's inability to perform requisite test measures as described in the study protocol

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Treatment and study plan

SoundArc

Device

non-surgical attachment method for wearing a bone conduction hearing system

Primary outcomes

  1. Patient Satisfaction Survey

    Time frame: one month post fitting

    To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)

  2. Percentage Correct on Word Identification Task

    Time frame: 4 weeks post fitting

    one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2017
Registry last updated
Apr 30, 2019

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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