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")

Sonitus Medical

Status and phase: Unknown; Phase 4

Conditions: Single Sided Deafness

Treatments: Device: SoundBite

Study type: Interventional

Funder types: Industry

Identifiers

NCT01933386

CLN008

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

SoundBite

Other group

Description:

SoundBite will be used for the first 30 days

Treatment:

Device: SoundBite

Surgically Implanted BCD

Other group

Description:

The subject's own surgically implanted bone conduction device will be used for the first 30 days.

Treatment:

Device: SoundBite