Efficacy of a Tinnitus Implant for People With Severe Tinnitus Without Damaging the Acoustic Hearing. (EESPIT)

Extracochlear Electrical Stimulation in Patients With Intractable Tinnitus - a Feasibility Study

This is a prospective, intervention-based, non-randomized, pre-post, single-site feasibility study that will involve data collection from individuals with intractable tinnitus. The study comprises a screening under local anesthesia and a surgery to implant the medical device. The screening will allow for accurate selection of patients. For patients not fulfilling the criteria for chronic extracochlear stimulation, the study will stop there. Patients eligible for chronic stimulation will undergo a second surgery under general anaesthesia involving the implantation of a cochlear implant with an electrode placed outside the cochlea in the vicinity of the round window. Each surgical procedure will be followed by a series of medical check-ups. Following implantation, the safety and efficiency of extracochlear chronic stimulation will be evaluated as well as the tinnitus suppression and speech perception.

Study Overview

• Status: Not yet recruiting
• Conditions: Tinnitus
• Intervention / Treatment: Device: Extracochlear stimulation

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mira Van Wilderode, PhD; Phone Number: 003232906000; Email: mira.vanwilderode@eiorl.be
• Study Contact Backup: Name: Andrzej Zarowski, MD; Phone Number: 003232906000; Email: andrzej.zarowski@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Proficient in written and spoken Dutch, defined by self-report or the researcher
• Intractable severe/uncompensated unilateral tinnitus, evaluated by VAS-score, and confirmed by Tinnitus functionality Index (TFI) and Tinnitus Questionnaire (TQ) (global TFI score of 54 and above and global TQ-score of 47 and above)
• Suffering from tinnitus for at least a year
• Not responsive to the normally available clinical tinnitus treatment.
• High-frequency sensorineural hearing loss in the ear to be treated
• Hearing aid did not provide any tinnitus suppression
• Ability to use the device and follow a personalized rehabilitation program.
• Ability to undergo the surgery

Exclusion Criteria:

• Chronic middle ear pathology
• Surgical anatomy not allowing for implantation, evaluated by CBCT/MRI imaging
• Tinnitus suppression is possible to achieve with hearing aids (as per self-report/documentation)
• Clinically significant depression (HADS-score of 11 and above)
• Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region
• Pregnant or breastfeeding women
• Current participation in another interventional clinical study/trial in the past 30 days involving an investigational drug or device.
• Medical contra-indications to middle ear surgery, and/or anesthesia
• Cholesteatoma in the ear to be treated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extracochlear stimulation; Implanted extracochlearly with a cochlear implant - active implantable medical device.	Device: Extracochlear stimulation; The study will implant a cochlear implant extracochlearly, near the round window.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	The primary objective of this clinical feasibility study is to evaluate safety of the cochlear implant system when implanted extracochlear, near the round window. The number of adverse events in each participant will be reported.	12 months post-operatively
Hearing loss	The primary objective of this clinical feasibility study is to evaluate safety, and usability of the cochlear implant system when implanted extracochlear, near the round window. This includes no major deterioration of hearing thresholds. Hearing thresholds will be measured by pure tone audiometry.	12months postoperatively
Tinnitus suppression	Demonstrate the efficiency of extracochlear electrical stimulation for tinnitus suppression after 6 and 12 months after chronic extracochlear electrical stimulation.The change in self-reported tinnitus severity after 12 months of chronic extracochlear electrical stimulation evaluated with the VAS-scores for tinnitus intensity and annoyance, and the TQ and TFI questionnaires.	6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
speech perception in quiet and in noise	Evaluate the effect on speech perception and sound quality of extracochlear electrical stimulation in the region of the round window at 12 months after implantation of the device.	12 months

Collaborators and Investigators

• Sponsor: ENTIC research and training centre of the European Institute for ORL

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus
• Other Study ID Numbers: TIN2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No