Using robotics and electrocochleography for cochlear implant surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility and proof of concept for integrating a robotic system with electrocochleography (ECochG) during cochlear implantation. The aim is to assess the effectiveness of the AIM System and iotaSOFT Insertion System in improving surgical outcomes for patients with sensorineural hearing loss. By collecting data on this integration, the study seeks to inform future clinical investigations in robotic-assisted cochlear implantation. Participants will undergo cochlear implantation using the Advanced Bionics SlimJ electrode array.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cochlear implant candidate in one or two ears per current FDA indications
2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
3. Cochlear implantation using the Advanced Bionics SlimJ electrode array
4. 18 years of age or older at the time of enrollment
5. Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria:

Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.

4\. History of temporal bone fracture that involves the cochlea/internal auditory canal.

5\. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).

6\. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.

7\. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.

8\. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.

9\. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.

10\. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Where it's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Study coordinator: Laura Chenier, Director of Clinical Affairs, AuD
• Email: lchenier@iotamotion.com
• Phone: 442-325-4171

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term hearing and speech outcomes after cochlear implants

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• Long-term outcomes of MED-EL SONATA 2 Cochlear Implants in real life

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• New software to help guide electrode insertion during cochlear implant surgery

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  Recruiting at 2 sites MED-EL Elektromedizinische Geräte GmbH · Innsbruck, Tyrol and 1 other locations · NCT07690995

• Perceptual adaptation after cochlear implantation

  This trial will try different frequency maps in adults who just received a cochlear implant in one ear to see which map improves sound quality, device use, and speech understanding.

  Recruiting NYU Langone Health · New York, New York · NCT07039435

• Robotic versus manual cochlear implant electrode insertion to reduce inner-ear trauma.

  This test tries a robotic insertion tool versus the usual manual technique to see if it reduces inner-ear damage and preserves residual hearing in people getting cochlear implants.

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• Comparing domestic and imported hearing aids for age-related hearing loss

  This study is testing whether hearing aids made in the U.S. work better than imported ones for older adults with age-related hearing loss.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT06882889

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.