Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · May 27, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how distance between cochlear implant electrodes and the cochlea (the part of the ear responsible for hearing) might relate to the development of fibrosis, which is a thickening or scarring of tissue that can affect hearing. By using advanced imaging techniques, the researchers hope to identify specific patterns that might indicate the presence of fibrosis in patients who have received cochlear implants. Understanding these patterns could help improve the outcomes of cochlear implants and enhance the quality of life for patients with hearing loss.

To be eligible for this study, participants must be 18 years or older and have a cochlear implant for at least six months, or they must be recently implanted with specific types of cochlear implants. They also need to be part of the French social security system and provide consent to participate. Participants will undergo imaging and assessments related to their cochlear implants, and the study is open to individuals of all genders. It’s important to note that those who use their cochlear implants for less than four hours a day or have certain health conditions may not qualify. This trial is currently recruiting participants and aims to provide valuable insights into how cochlear implants can be optimized for better hearing results.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Group with long-term implantation:
• • Age18 years or older
• • Affiliation to the French social security
• • Signed and dated informed consent form
• • Users of uni or bilateral cochlear implants for more than 6 months (CI24CA, CI422, CI512, CI522, CI532, CI612; CI622; CI632), in primo-implantation or reimplantation, with more than 18 electrodes active
• • Postoperation CBCT imaging results available
• Recently-implanted group:
• • Age18 years or older
• • Affiliation to the French social security
• • Signed and dated informed consent form
• • Indication for CI622 or CI632 cochlear implants
• • Postoperation CBCT imaging results available
• Exclusion Criteria:
• • Vulnerable individuals (minors, adults protected in accordance to the French Public Health code, patients deprived of liberty by court decision)
• • Daily usage of the cochlear implant for less than 4 hours or weekly usage for less than 5 days
• • Failure or disfunction of the cochlear implant