N/A N=35 Treatment

Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

Unilateral Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT00977314 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Incidence of Device- and Procedure-related Adverse Events at 30 Days — 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: The Sonitus Bone Conduction Hearing System (Device); SoundBite (Device); SoundBite Hearing System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sonitus Medical Inc
Primary completion: Feb 2010

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	—

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).

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

View full record on ClinicalTrials.gov →

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.