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")

Single Sided Deafness Clinical Trial

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")

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01933386
• Other study ID #: CLN008
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 28, 2013
• Last updated: October 25, 2013
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2013
• Source: Sonitus Medical Inc
• Contact: Linda Galow, M.S.
• Phone: 1-650-581-5094
• Email: linda[@]sonitusmedical.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Single Sided Deafness

Intervention

Device:
• SoundBite
Non-surgical removable bone conduction device via the teeth.

Locations

Country	Name	City	State
United States	Michigan Ear Institute	Novi	Michigan
United States	Arizona Ear Center	Phoenix	Arizona
United States	Ear Medical Group	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sonitus Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	APHAB Questionnaire	Comparison of the SoundBite™ System and surgically implanted bone conduction devices	30 days	No
Secondary	Single Sided Deafness Questionnaire	Comparison of the SoundBite™ System and surgically implanted BCD systems.	30 days	No

External Links

•   SoundBite Hearing System