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

N/ANot Yet RecruitingNCT07648615

ENTIC research and training centre of the European Institute for ORL6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tinnitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months and 12 months

Secondary Outcomes

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.

Time frame: 12 months