To assess the efficacy of the Tinnitus Implant System on tinnitus loudness in adults with moderate to severe chronic tinnitus accompanied by normal hearing to moderately severe hearing loss at 6 months post-activation of the Tinnitus Implant System…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinically significant improvement from baseline to 6 months post-activation of
the Tinnitus Implant System in the Visual Analogue Scale on tinnitus loudness
(VAS-L) as a continuous outcome (with a clinically relevant difference of
>=15/100 points).
Secondary outcome
* Device or procedure related adverse events.
* Reported harms.
* Clinically significant improvement from baseline in Visual Analogue Scale
Annoyance (VAS-A) as a continuous outcome (with a clinically relevant
difference of >=15/100 points).
* Clinically significant improvement from baseline in Tinnitus Functional Index
(TFI) as a continuous outcome (with a clinically relevant difference of >=13
points).
* Tinnitus matching (loudness and pitch) as exploratory measures.
* Score of Glasgow Benefit Inventory (GBI).
* Score of Patient Global Impression of Change (PGIC).
* Clinically significant worsening in speech perception in quiet from baseline
in the unaided condition (with a clinically relevant difference of >20%-point
word recognition score) in the implanted ear.
* Clinically significant worsening in bone conduction thresholds in any tested
frequency (0.25, 0.5, 1, 1.5, 2, 4 kHz) from baseline (with a clinically
relevant difference of >10 dB) in the implanted ear.
Background summary
Tinnitus is the conscious perception of a sound in the absence of an external
auditory input, often experienced as a ringing or buzzing sound in the ear or
the head. Tinnitus occurs with a prevalence ranging from 10% to 15%, and
severely impairs quality of life of about 1-2% of all people1,2. Tinnitus
management and compensation also cause significant burdens for the health
system. For example, in 2012, the United States Department of Veterans Affairs
spent USD 1.2 billion on tinnitus-related compensation to veterans.
There is not an established standard of care, and of the currently available
treatments, cognitive behaviour therapy (CBT) is the most utilized. CBT is a
psychological-based therapy whose goal is to identify and modify maladaptive
behaviors and negative thoughts resulting in tinnitus distress. While CBT has
shown effectiveness in reducing tinnitus burden, the tinnitus itself remains
untreated.
Research has shown that electrical stimulation through cochlear implantation
has positive effects on tinnitus loudness and distress as a secondary benefit
in addition to restoration of hearing function4-6. However, because cochlear
implants are indicated for patients with moderate to profound hearing loss,
there remains no effective treatment for the majority of patients suffering
from tinnitus. Over 90% of patients seeking help for tinnitus have near normal
hearing to moderate hearing loss and do not meet the audiological criteria for
a cochlear implant.
Given the evidence of the positive impact of electrical stimulation by cochlear
implants on tinnitus loudness and distress, Cochlear has been researching the
potential of a less invasive middle ear tinnitus implant to provide
extracochlear electrical stimulation. Doing so could offer an effective
treatment without damaging hearing for a broader population of patients seeking
help for tinnitus. There is no device available today that can offer patients
suffering with severe tinnitus a stable and substantial reduction of tinnitus
loudness.
The Tinnitus Implant System (TINIS) is an Active Implantable Medical Device
intended for use in adults with normal hearing to moderately severe hearing
loss and moderate to severe tinnitus. It is currently available for research
and clinical trial purposes only. The device is based on a conventional
cochlear implant that uses the extracochlear hardball electrode placed on the
promontory as a stimulating electrode. Stimulation of the auditory nerve is
achieved in the same way as for a standard CI with the aim of reducing tinnitus
loudness.
Informed by data from a preliminary feasibility study that demonstrate a
reasonable expectation the device could 1) function as intended and 2) more
effectively treat severe tinnitus than current alternatives, Cochlear is
planning to pursue marketing authorization of the Tinnitus Implant System once
sufficient evidence is gathered from additional premarket activities.
Study objective
To assess the efficacy of the Tinnitus Implant System on tinnitus loudness in
adults with moderate to severe chronic tinnitus accompanied by normal hearing
to moderately severe hearing loss at 6 months post-activation of the Tinnitus
Implant System.
Study design
This is a prospective, multicentre, feasibility investigation in patients with
moderate to severe chronic tinnitus accompanied by normal hearing to moderately
severe hearing loss.
Intervention
The Tinnitus Implant System is intended for long term implantation in the
mastoid region of either side of the head and is intended to reduce tinnitus
loudness via electrical stimulation of the auditory nerve. The processor unit
powers the tinnitus implant via a coil. The implant provides reduction in
tinnitus loudness by electrical stimulation of the auditory nerve via the
promontory.
Study burden and risks
Previous research suggests that electrical stimulation of the auditory nerve
can reduce tinnitus loudness, as shown with cochlear implants placed within the
cochlea as well as on the promontory of the cochlea (IDE G180194). Therefore,
benefits of the Tinnitus Implant System to the subject are expected to include
a reduction in tinnitus loudness without compromising hearing. The additional
risks associated with the Tinnitus Implant System have been assessed and do not
alter the conclusion that the potential benefits outweigh the risks for the
investigational device
Schaliënhoevedreef 20/l
Mechelen 2800
BE
Schaliënhoevedreef 20/l
Mechelen 2800
BE
Listed location countries
Age
Inclusion criteria
1) 18 years or older.
2) 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).
3) Unilateral or asymmetric subjective (no pulsatile) tinnitus. In case of
asymmetric tinnitus, the worst ear must be implanted.
4) Tinnitus duration of at least 6 months.
5) Severe tinnitus loudness determined by
a. VAS-L score in the severe range i.e. 50-100/100.
b. TFI score in the severe range i.e. 52-90/100
6) Tinnitus that is intractable and has not been ameliorated satisfactorily by
standard of care such as CBT or hearing aid, when such interventions are
potentially clinically indicated.
7) Clinically significant reduction in VAS-L score (>= 15/100 points) in
response to
trans-tympanic promontory stimulation
8) Willing and able to provide written informed consent.
9) Medically able to use the device and to undergo general anaesthesia for
implantation taking into account their medical condition, contraindications and
surgical risks.
10) Dutch language proficiency
Exclusion criteria
1) Pulsatile tinnitus.
2) 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
3) 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).
4) 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).
5) Presence of clinically diagnosed depression or anxiety determined by a
psychological state evaluation (if PHQ-9 > 9 or GAD-7 > 9).
6) Active (currently or within two months prior to enrolment) use of medications
(taking regularly scheduled antidepressant, anxiolytic, antipsychotic or
antiepileptic medications, or other neuromodulator agents) or other tinnitus
treatments.
a. It is permissible to include people who use such medications at lower
doses as a sleep aid or for people who intermittently use such
medications for situational anxiety (e.g., Ativan before airplane travel).
A change in medication during the trial should be avoided.
b. It is permissible to include people who prefer to use a hearing aid to
amplify ipsilateral hearing loss. The start of using a hearing aid during
the trial should be avoided.
7) Investigator site personnel directly affiliated with this study and/or their
immediate families; immediate family is defined as a spouse, parent, child, or
sibling.
8) Cochlear employees or employees of Contract Research Organizations or
contractors engaged by Cochlear for the purposes of this investigation.
9) Current participation, or participation in another interventional clinical
study/trial in the past 60 days, involving an investigational drug or device
(unless the other investigation was/is a Cochlear sponsored investigation and
determined by the investigator or Sponsor to not impact this investigation).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06641999 |
| CCMO | NL87958.000.24 |