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

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.

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Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracochlear stimulation

Device

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

Primary outcomes

Number of participants with treatment-related adverse events

Time frame: 12 months post-operatively

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.
Hearing loss

Time frame: 12months postoperatively

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.
Tinnitus suppression

Time frame: 6 months and 12 months

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.

Secondary outcomes

speech perception in quiet and in noise

Time frame: 12 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrzej Zarowski, MD

CONTACT

[email protected]

003232906000

Mira Van Wilderode, PhD

CONTACT

[email protected]

003232906000

Sponsors and collaborators

Lead sponsor

ENTIC research and training centre of the European Institute for ORL

Network

Registry information

Official study title

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

Acronym: EESPIT

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 15, 2026
Registry last updated: Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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