Trials / Completed
CompletedNCT03333577
Evaluation of the Baha SoundArc in Pediatric Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 5 Years – 12 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SoundArc | non-surgical attachment method for wearing a bone conduction hearing system |
Timeline
- Start date
- 2017-11-02
- Primary completion
- 2018-11-02
- Completion
- 2018-11-02
- First posted
- 2017-11-07
- Last updated
- 2019-04-30
- Results posted
- 2019-04-11
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03333577. Inclusion in this directory is not an endorsement.