Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

Sensorineural Hearing Loss, Bilateral Clinical Trial

— PROGRESS  

Official title:

Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265260
• Other study ID #: EMEA5798
• Status: Completed
• Start date: April 21, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: October 2023
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult subjects, 18 years or older

• Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.

• Subjects who have been implanted between January 2016 and December 2021.

• Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types.

• Subjects who are fluent in French (language used in the questionnaire and speech tests)

• Subjects who are not opposed to participating in the study

• Subjects for who the medical record data is available throughout the defined data search period.

Exclusion Criteria:

• Subjects with single-sided deafness (SSD).

• Subjects who are not affiliated to the French Social Security.

• Subjects who are under legal protection.

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss, Bilateral

Locations

Country	Name	City	State
France	Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the French MBAA2 Sentence Recognition Test in Quiet	Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of =90/100 correct sentence. A bad performer has a score of <90/100 correct sentence.	1 month post activation