Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression

EstimME

Status: Completed

Conditions: Tinnitus

Treatments: Device: Nimbus Multifunctional Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01549145

EST-01-IL

Details and patient eligibility

About

The objectives of this study are to evaluate the safety and efficacy of applying electrical stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic stimulation regimen.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Total score on the Handicap Inventory (THI) of at least 40.
2. Visual scale over 5.
3. Tinnitus origin is peripheral (related to long term noise exposure, or to a sudden exposure to a very loud noise etc.)
4. Tinnitus is on-going; present for more than 50% of the time over the past 12 months.
5. Unilateral tinnitus
6. Tinnitus prevalent at least 12 months.
7. Willingness to abstain from part taking in other, non-study procedures indicated to lessen tinnitus and/or its perception.
8. Willing and able to refrain from engaging in activities or work involving loud noise exposure.
9. Male or females 18-60 years of age

Exclusion criteria

1. Prior history of sudden hearing loss and/or fluctuating hearing levels.
2. Tinnitus prevalent more than 3 years.
3. History of frequent middle ear infections
4. Patient under immunosuppressant therapy
5. Auditory nerve damage.
6. Vestibular Schwannoma
7. Cochlear implant.
8. Pregnant or lactating.
9. Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
10. Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
11. Not being physically or geographically capable of returning for scheduled follow-up visits.
12. Any physical, psychological, or emotional disorder that would interfere with the planned surgical operations
13. Mentally retarded, developmentally delayed or suffering from organic brain dysfunction.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

NIMBUS multifunctional stimulator

Experimental group

Description:

A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)

Treatment:

Device: Nimbus Multifunctional Stimulator