Auditory Intranerve Stimulation Perceptual Study (ANI-NIH)
24. august 2026 oppdatert av: Hannover Medical School
Scientific Assessment of Auditory Intranerve Stimulation Loudness and Pitch Percepts
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The auditory nerve implant (ANI) targets the auditory nerve directly between the cochlea and the brainstem, whereas current implants like the cochlear and brainstem implants stimulate the cochlea or brainstem, respectively. By providing direct stimulation within the auditory nerve, a nerve implant offers a better electrode-nerve interface and may achieve improved hearing compared to a cochlear or brainstem implant. Preliminary results in animals, computer simulations, and acute clinical studies showed significantly better performance compared to other hearing aidsoptions. This study aims to investigate the extent to which these benefits are perceptible in the human auditory nerve.
The primary goal of this study is to gain scientific insight into the hearing experience with the direct auditory nerve stimulation. However, the results could contribute to the development of new hearing implants that directly stimulate the auditory nerve.
Studietype
Intervensjonell
Registrering (Antatt)
5
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hubert Lim, Prof.
- Telefonnummer: +16126264565
- E-post: Hlim@umn.edu
Studiesteder
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Hanover, Tyskland, 30625
- Rekruttering
- Hannover Medical School
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Ta kontakt med:
- Karl-Heinz Dyballa
- Telefonnummer: +4917615328589
- E-post: dybala.karl-heinz@mh-hannover.de
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Underetterforsker:
- Rolf Salcher, Dr.
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Underetterforsker:
- Max Timm, Dr
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Underetterforsker:
- Waldo Nogueira, Prof.
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Underetterforsker:
- Karl-Heinz Dyballa, Dr.
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Hovedetterforsker:
- Thomas Lenarz, Prof.
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Hanover, Tyskland, 30625
- Aktiv, ikke rekrutterende
- Service provider for the performance of surgical procedures: International Neuroscience Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
- Functional auditory nerve and central auditory pathway
- Post-linguistic onset of ipsilateral severe-to-profound hearing loss
- The contralateral ear has sufficient vestibular function
Women not able to become pregnant*
Women not able to become pregnant defined as follows:
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- hysterectomy or uterine agenesis or
- ≥ 50 years and in postmenopausal state > 1 year or
- < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening
Exclusion Criteria:
- 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
- Persons who are deprived of their liberty on the basis of an official order or a court order or authorization
- Known allergies to one of the components of the implant (medical grade silicone, Parylene-C, Iridium oxide, Platinum-Iridium alloy (PtIr 10) and (PtIr 20) )
- Other active devices with potential interference with the auditory nerve implant
- Presence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull
- Additionally, in the event of other health issues, the investigators will decide on a case-by-case basis whether to enroll the patientparticipant in the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Enhetens gjennomførbarhet
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Experimental: Direct Auditory Nerve Stimulation
Patients Participants will be implanted with an Auditory Nerve Implant (ANI) for one year to evaluate key perceptual measures of temporary direct auditory nerve stimulation.
Safety and efficacy will also be evaluated, as well as different speech perception capabilities.
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The investigational research device consists of a speech processor worn on the ear and an implant body with an electrode array.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pitch perception performance of ANI
Tidsramme: 12 months
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Systematic place pitch ordering maintained on month 12
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Loudness perception performance of ANI
Tidsramme: 12 months
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Collection of loudness growth functions (LGFs) across single electrodes that have a dynamic range greater than 6 dB and maintained on month 12
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12 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency Resolution
Tidsramme: 12 months
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Minimum frequency specificity (i.e., current spread) of electrodes is narrower than 0.8 mm in bandwidth maintained on month 12
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12 months
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Position of ANI electrode array in auditory nerve
Tidsramme: 12 months
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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.
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12 months
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Collection of adverse events
Tidsramme: 12 months
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Collection of adverse events during the evaluation period
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Thomas Lenarz, Prof., Hannover Medical School
- Hovedetterforsker: Amir Samii, Prof., International Neuroscience Institute Hannover
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
29. februar 2028
Studiet fullført (Antatt)
29. februar 2028
Datoer for studieregistrering
Først innsendt
12. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
27. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0000509678
- No.11979-BO-MPDG-M-2025 (Annen identifikator: Ethics committee Hannover Medical School)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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