Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation

NCT06301568 | Completed Results

• 1 other identifier: ABIntl-23-12
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.

Conditions

Cochlear Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Freiburger Monosyllabic Word Recognition Score in Quiet

  Percent correct in the Freiburger Monosyllabic Word test

  The Freiburger monosyllabic word test is performed 12 months after device activation

Secondary Outcomes (1)

• Hochmair-Desoyer Schultz and Moser (HSM) Sentence Score or Oldenburger Sentence Test (OlSa) Recognition Score in Quiet

  The test (HSM or OlSa) is performed 12 months after device activation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The studied population consists of all CI users implanted with a HiRes Ultra or HiRes Ultra 3D SlimJ between January 2017 and August 2022 and using an acoustic earhook at the Medical University of Hannover in Germany (MHH)

You may qualify if:

• Being implanted with HiRes Ultra or HiRes Ultra 3D SlimJ
• Being a user of the "acoustic earhook" system
• Having provided informed consent regarding use of his/her data for research.

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Caroline-Marie Delattre
• Organization: Advanced Bionics

caroline-marie.delattre@advancedbionics.com

+33788667472

Study Officials

• Andreas Büchner

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: January 22, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 2, 2024
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-02

Locations

DE (1)