Auditory Intranerve Stimulation Perceptual Study

ConditionDeafness, Perception

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorHannover Medical School

About this trial

The objective of this scientific study is to evaluate the feasibility of direct auditory nerve stimulation to elicit key percepts, specifically loudness and frequency/pitch percepts in three deaf patients participants with the new auditory nerve implant (ANI). During the year with temporary stimulation of the auditory nerve, patients participants are expected to participate for 14 months, consisting of: two months for surgery for the nerve implant and healing phase, one month initial follow-up, ten months of follow-up care and study testing, and one month for explanation and post-operative observation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤85 years

Written informed consent

Bilateral deafness with cochlea that does not allow the implantation of a cochlear implant (CI). This can include ossification, malformation of cochlea; poor CI performers (lowest quartile of CI performance); and patientparticipants with facial nerve stimulation using a CI which is not manageable without reduction of performance

Eligible for routine auditory brainstem implant (ABI) where patientparticipants would undergo more invasive brainstem surgery than the ANI surgery

Disqualifiers

Medical, neurological, or psychological conditions that would contraindicate undergoing surgery, e.g. depression, acute cardiac infarction, history of stroke, dementia, epilepsy

Additional handicaps that would prevent participation in evaluations

Women able to become pregnant

Pregnant women

Trial design

Design model

Single group

Treatments tested in this trial

Auditory Nerve Implant (ANI)
Device
The investigational research device consists of a speech processor worn on the ear and an implant body with an electrode array.

Treatment groups

5 Participants

are divided into 1 treatment group

Group A: Experimental: Direct Auditory Nerve StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pitch perception performance of ANI

Systematic place pitch ordering maintained on month 12

Time frame

12 months

Secondary outcomes

Loudness perception performance of ANI

Collection of loudness growth functions (LGFs) across single electrodes that have a dynamic range greater than 6 dB and maintained on month 12

Time frame

12 months

Other outcomes

Frequency Resolution

Minimum frequency specificity (i.e., current spread) of electrodes is narrower than 0.8 mm in bandwidth maintained on month 12

Time frame

12 months

Position of ANI electrode array in auditory nerve

Evaluation of the final position of the ANI electrode array. The number of electrodes eliciting auditory activation will be measured. The stability of the percepts elicited will also be measured. Both of these measurements provide the stability of the electrode array implanted within the auditory nerve.

Time frame

12 months

Collection of adverse events

Collection of adverse events during the evaluation period

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hannover Medical School

Lead sponsor

Source ClinicalTrials.gov

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