Status:

COMPLETED

Evaluation of the Baha SoundArc in Pediatric Patients

Lead Sponsor:

Cochlear

Conditions:

Hearing Loss, Conductive

Hearing Loss, Mixed

Eligibility:

All Genders

5-12 years

Phase:

NA

Brief Summary

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

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 the...

Eligibility Criteria

Inclusion

  • • 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

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

Key Trial Info

Start Date :

November 2 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 2 2018

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT03333577

Start Date

November 2 2017

End Date

November 2 2018

Last Update

April 30 2019

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Arizona Hearing and Balance

Chandler, Arizona, United States, 85224

2

Rady Children's Hospital

San Diego, California, United States, 92123

3

Cook Children's Hospital

Fort Worth, Texas, United States, 76104