Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant

Advanced Bionics

Status: Enrolling

Conditions: Cochlear Hearing Loss

Study type: Observational

Funder types: Industry

Identifiers

NCT06301581

ABIntl-23-42

Details and patient eligibility

About

This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including

  • Ultra Version V2 newly implanted on this side (Group 1)
  • Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2)

• Informed consent signed

Exclusion criteria

• no exclusion criteria

Trial design

200 participants in 2 patient groups

Group 1

Description:

HiRes Ultra or HiRes Ultra 3D Version V2 newly implanted on this side

Group 2

Description:

HiRes Ultra or HiRes Ultra 3D Version V2 implanted following an Ultra Version V1 device failure on the same ear