Trial Outcomes & Findings for Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation (NCT NCT06301568)

Results Overview

Percent correct in the Freiburger Monosyllabic Word test

Recruitment status

COMPLETED

Target enrollment

55 participants

Primary outcome timeframe

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

Results posted on

2026-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	EAS CI Users adult EAS CI users implanted with an Ultra or Ultra 3D SlimJ implant between 2018 and 2023
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EAS CI Users n=55 Participants adult Electro-Acoustic Stimulation (EAS) Cochlear Implants (CI) users implanted with an Ultra or Ultra 3D SlimJ implant between 2018 and 2023
Age, Continuous	62.3 years STANDARD_DEVIATION 15.5 • n=55 Participants
Sex: Female, Male Female	31 Participants n=55 Participants
Sex: Female, Male Male	24 Participants n=55 Participants
duration of hearing impairment	25.4 years STANDARD_DEVIATION 17.5 • n=55 Participants
duration of CI use	3.8 years STANDARD_DEVIATION 2.1 • n=55 Participants

PRIMARY outcome

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

Population: Results of the Freigburger test are available for 23 subjects at 12m. Although 55 patients were included in this retrospective study, data at 12 months is not available for all the subjects.

Percent correct in the Freiburger Monosyllabic Word test

Outcome measures

Outcome measures
Measure	EAS CI Users n=23 Participants adult EAS CI users implanted with an Ultra or Ultra 3D SlimJ implant between 2018 and 2023
Freiburger Monosyllabic Word Recognition Score in Quiet	50.6 Percent correct in the Freiburger Monosy Standard Deviation 23.8

SECONDARY outcome

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

Population: Results of the sentence test are available for 17 subjects at 12m. Although 55 patients were included in this retrospective study, data at 12 months is not available for all the subjects.

Percent correct in either the HSM sentence test or the Oldenburger sentence test (score from 0 to 100%)

Outcome measures

Outcome measures
Measure	EAS CI Users n=17 Participants adult EAS CI users implanted with an Ultra or Ultra 3D SlimJ implant between 2018 and 2023
Hochmair-Desoyer Schultz and Moser (HSM) Sentence Score or Oldenburger Sentence Test (OlSa) Recognition Score in Quiet	75.6 percent correct in either the HSM senten Standard Deviation 22.7

Adverse Events

EAS CI Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Caroline-Marie Delattre

Advanced Bionics

Phone: +33788667472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60