N/A
Completed N=35
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Unilateral Hearing Loss
Source: ClinicalTrials.gov NCT00977314 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Incidence of Device- and Procedure-related Adverse Events at 30 Days — 0 participants
Summary
The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Device- and Procedure-related Adverse Events at 30 Days |
— | — |
| PRIMARY Efficacy: Ability to Understand Speech in Noise |
-2.5 | <0.001 sig |
| SECONDARY Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB). |
18.80 | — |
Eligibility Criteria
Inclusion Criteria
- Must be >18, 10dB HL at more than 3 frequencies)
- Word recognition scores inconsistent with pure tone averages
- Fluctuating hearing loss
- Must not have known psychological factors that interfere with their ability to comply, comprehend, consent and cooperate
Data sourced from ClinicalTrials.gov (NCT00977314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.