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ClinicalTrials.gov ID

NCT01933386

Lead Sponsor

Sonitus Medical IncINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

15Estimated

Last Update Posted

Oct 29, 2013Estimated

Start Date

Sep 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

Feb 2014Estimated

Official Title

Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")

Brief Summary

The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.

• Single Sided Deafness

• SoundBite

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device
• Must be >18, <80 years old
• Must be fluent in English, as determined by the PI
• Must have diagnosis of SSD, time since onset (≥3 months)
• Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite
• Healthy attachment to those teeth with tooth pockets limited to no more than 5mm

Exclusion Criteria:

• Subjects with known hypersensitivity to any of the components including allergies to polymers.
• Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling.
• Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Sonitus Medical IncINDUSTRY

Jennifer.Monitz@providence-stjohnhealth.org248-465-4828

RobynS@earmedicalgroup.com210-614-6070