Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCochlear
About this trial
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
Normal hearing to moderately severe sensorineural hearing loss defined as a pure tone average (PTA) at 500, 1000, 2000 and 4000 Hz less than 65 dB HL in both ears (separately) and best-aided phoneme recognition score more than or equal to 80% in both ears (separately).
Unilateral or asymmetric subjective (no pulsatile) tinnitus. In case of asymmetric tinnitus, the worst ear must be implanted.
Tinnitus duration of at least 6 months.
Disqualifiers
Pulsatile tinnitus.
Any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (determined in a temporal bone CT and if necessary (e.g. possibility of vestibular/acoustic schwannoma) by a MRI scan of the head (of sufficient quality at the discretion of the investigator) not more than five years old at the time of enrolment
Medical contraindications limiting correct placement, activation, or treatment (determined by medical history; contraindications include brain or major ear surgery, brain or temporal bone tumor(s), recurrent ear infections within the last year, otosclerosis, prior major head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment).
Any medical condition, including mental illness or substance abuse, deemed by the Investigator to likely interfere with a patient's ability to sign informed consent, cooperate and/or participate in the study, or interfere with the interpretation of the results (incl. pregnant or breastfeeding women or patients with unrealistic expectations).
Trial design
Design model
Single group
Treatments tested in this trial
Tinnitus Implant System
DeviceImplanted with Tinnitus Implant System: Active Implantable Medical Device
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Tinnitus Implant SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean change in tinnitus loudness from baseline to 6 months post-activation of the Tinnitus Implant System
Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Loudness (VAS-L) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest loudness severity
Time frame
Pre-operative baseline to 6 months post Tinnitus Implant System activationSecondary outcomes
1
Reported device or procedure related adverse events and harms
Number of device and procedure-related adverse events and reported harms
Time frame
Pre-operative baseline to 6 months post Tinnitus Implant System activation2
Mean change in tinnitus annoyance from baseline to 6 months post activation of the Tinnitus Implant System
Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Annoyance (VAS-A) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest annoyance severity
Time frame
Pre-operative baseline to 6 months post Tinnitus Implant System activation3
Mean change in tinnitus perception from baseline to 6 months post activation of the Tinnitus Implant System
Self-reporting on the Tinnitus Functional Index (TFI) questionnaire
Time frame
Pre-operative baseline to 6 months post Tinnitus Implant System activation4
Change in self-reported matches of tinnitus pitch and loudness to acoustic stimuli
Patient reported matching of tinnitus pitch (Hz) and loudness (dB SPL) with acoustic stimuli
Time frame
Pre-operative baseline, activation (Implant activation is approximately 10 weeks after surgical implantation of Tinnitus implant), 3 months post activation, 6 months post activation Source ClinicalTrials.gov