Auditory Intranerve Stimulation Perceptual Study

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for 3 adults who are deaf in both ears and cannot use a cochlear implant. They will receive a new auditory nerve implant (ANI) for about one year.

Életkor

18 to 85 years

Nem

All sexes. Women can join only if they cannot become pregnant.

A betegség stádiuma

Deafness in both ears. The inner ear (cochlea) does not allow a cochlear implant, for example because it has turned to bone or is malformed. People who do very poorly with a cochlear implant (lowest quartile), or whose implant stimulates the face nerve in a way that cannot be managed, can also join. Severe-to-profound hearing loss on the implant side began after learning to speak. The hearing nerve and brain hearing pathways must work. The other ear must have enough balance function. People must be able to have a routine auditory brainstem implant (ABI).

A részvétel fő kizáró okai

• Health, nerve or mental conditions that make surgery unsafe, such as depression, recent heart attack, past stroke, dementia or epilepsy
• Women who can become pregnant, or are pregnant
• Allergy to implant materials such as medical grade silicone, Parylene-C, Iridium oxide or Platinum-Iridium alloy
• Other active devices that could interfere with the implant
• Skull shape problems that prevent placing the implant in the skull bone

A regiszter feltételei, szó szerint

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• 18 és 85 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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.

A vizsgálat csoportja

• Experimental: Direct Auditory Nerve StimulationA vizsgált kezelés

  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.

  Kezelés: Auditory Nerve Implant (ANI)