Evaluation of the Baha SoundArc in Pediatric Patients

April 16, 2019 updated by: Cochlear
The purpose of this study is to gather clinical performance data on the Baha SoundArc

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Hearing and Balance
    • California
      • San Diego, California, United States, 92123
        • Rady Children's Hospital
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental SoundArc study group
all subjects will receive the SoundArc intervention
Device: SoundArc
non-surgical attachment method for wearing a bone conduction hearing system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one month post fitting
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.
4 weeks post fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: George Cire, Study Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2017

Primary Completion (ACTUAL)

November 2, 2018

Study Completion (ACTUAL)

November 2, 2018

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (ACTUAL)

November 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM5714

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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