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

NCT07648615 | Not Yet Recruiting

• 1 other identifier: TIN2025
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• speech perception in quiet and in noise

  12 months

Study Arms (1)

Extracochlear stimulation

EXPERIMENTAL

Implanted extracochlearly with a cochlear implant - active implantable medical device.

Device: Extracochlear stimulation

Interventions

Extracochlear stimulation DEVICE

The study will implant a cochlear implant extracochlearly, near the round window.

Extracochlear stimulation

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mira Van Wilderode, PhD

CONTACT

003232906000; mira.vanwilderode@eiorl.be

Andrzej Zarowski, MD

CONTACT

003232906000; andrzej.zarowski@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share