Brief Summary

The aim of this clinical study is to investigate how the fitting of an EAS (electrical acoustic stimulation) based on electrocochleography (ECochG) thresholds compares to fitting based on pure tone audiogram thresholds in terms of speech intelligibility in quiet and noise. The personal feedback from the study participants regarding the question of better fitting and the resulting sound quality should also be included in the analysis.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

14mo left

Started May 2026

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Progress19%

May 2026Nov 2027

First Submitted

Initial submission to the registry

March 12, 2026

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed

2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

March 12, 2026

Last Update Submit

April 23, 2026

Conditions

Fitting Methods by EAS Patients

Keywords

Cochlear Implant patientsResidual hearing in the low frequency rangeEASfitting methodselectrocochleography

Outcome Measures

Primary Outcomes (1)

Speech Recognition Threshold (SRT50)
The primary outcome measure is the Speech Recognition Threshold (SRT50) at three months after EAS fitting (either objective or subjective EAS fitting in a cross-over design). The SRT50 measures speech understanding in noise and is defined as the Signal-to-Noise Ratio (measured in dB SNR) which yields 50% speech understanding, as determined by the OLSA test.
Three months after EAS fitting

Secondary Outcomes (3)

Subjective level of auditory benefit
Three months after EAS fitting
Subjectively preferred EAS fitting method
at the end of the study, six months after baseline
Post-operative ECochG and PTA tresholds
Three months after EAS fitting (either objective or subjective EAS fitting)

Study Arms (2)

Sequence A, subjective followed by objective fitting

OTHER

In this sequence, the EAS is fitted in the first three months (period 1) using the subjective fitting method based on the thresholds in the pure tone audiogram. This is followed by three months (period 2) fitting using the objective fitting method based on the thresholds from electrocochleography.

Other: The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study.Other: The subjective adjustment of an EAS based on thresholds from the pure tone audiogram.

Sequence B, objective followed by subjective fitting

OTHER

In this sequence, the EAS is fitted in the first three months (period 1) using the objective fitting method based on the thresholds from electrocochleography. This is followed by three months (period 2) fitting using the subjective fitting method based on the thresholds in the pure tone audiogram.

Interventions

The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study.OTHER

Measured ECochG thresholds will be used in the initial EAS fitting in period 1 for sequence B. For sequence A, the ECochG-based EAS fitting (with up-to-date ECochG thresholds) will take place three months later at the beginning of period 2.

Sequence A, subjective followed by objective fittingSequence B, objective followed by subjective fitting

The subjective adjustment of an EAS based on thresholds from the pure tone audiogram.OTHER

The control intervention is the subjective EAS fitting based on PTAs. This is provided to sequence A at the beginning of period 1 baseline and to sequence B at the beginning of period 2.

Sequence A, subjective followed by objective fittingSequence B, objective followed by subjective fitting

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients aged between 18-85 years.
Cochlear Implant (CI) candidates with measurable post-operative low-frequency residual hearing (125Hz \<65dB, 250Hz \<65dB, 500Hz \<65dB).
Only patients with MED-EL EAS.
Written informed consent must be obtained prior to study start.

You may not qualify if:

Patients with cognitive impairments who, as a result, lack the capacity to make decisions.
Uncooperative patients regarding pure tone audiometry thresholds measurements.
Morbus Menière or intracochlear/ vestibular schwannoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Luzerner Kantonsspitallead
MED-EL Elektromedizinische Geräte GesmbHcollaborator

Related Publications (9)

Schaefer S, Sahwan M, Metryka A, Kluk K, Bruce IA. The benefits of preserving residual hearing following cochlear implantation: a systematic review. Int J Audiol. 2021 Aug;60(8):561-577. doi: 10.1080/14992027.2020.1863484. Epub 2021 Jan 10.
PMID: 33426931BACKGROUND
Rajan G, Tavora-Vieira D, Baumgartner WD, Godey B, Muller J, O'Driscoll M, Skarzynski H, Skarzynski P, Usami SI, Adunka O, Agrawal S, Bruce I, De Bodt M, Caversaccio M, Pilsbury H, Gavilan J, Hagen R, Hagr A, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Yongxin L, Lorens A, Manoj M, Martin J, Mertens G, Mlynski R, Parnes L, Pulibalathingal S, Radeloff A, Raine CH, Rajeswaran R, Schmutzhard J, Sprinzl G, Staecker H, Stephan K, Sugarova S, Zernotti M, Zorowka P, Van de Heyning P. Hearing preservation cochlear implantation in children: The HEARRING Group consensus and practice guide. Cochlear Implants Int. 2018 Jan;19(1):1-13. doi: 10.1080/14670100.2017.1379933. Epub 2017 Oct 26.
PMID: 29073844BACKGROUND
15. Wagener KC, Kühnel V, Kollmeier B (1999b) Entwicklung und Evaluation eines Satztests für die deutsche Sprache III: Evaluation des Oldenburger Sprachtests. Z Audiol 38:86-95.
BACKGROUND
Wagener KC, Kühnel V, Kollmeier B (1999a) Entwicklung und Evaluation eines Satztests für die deutsche Sprache I: Design des Oldenburger Satztests. Z Audiol 38:4-15.
BACKGROUND
Hey M, Bohnke B, Mewes A, Munder P, Mauger SJ, Hocke T. Speech comprehension across multiple CI processor generations: Scene dependent signal processing. Laryngoscope Investig Otolaryngol. 2021 Jun 15;6(4):807-815. doi: 10.1002/lio2.564. eCollection 2021 Aug.
PMID: 34401506BACKGROUND
Gifford RH, Sunderhaus LW, Dawant BM, Labadie RF, Noble JH. Cochlear implant spectral bandwidth for optimizing electric and acoustic stimulation (EAS). Hear Res. 2022 Dec;426:108584. doi: 10.1016/j.heares.2022.108584. Epub 2022 Jul 28.
PMID: 35985964BACKGROUND
Gawliczek T, Mantokoudis G, Anschuetz L, Caversaccio MD, Weder S. Comparison of auditory brainstem response and electrocochleography to assess the coupling efficiency of active middle ear implants. Front Neurol. 2023 Sep 6;14:1231403. doi: 10.3389/fneur.2023.1231403. eCollection 2023.
PMID: 37745650BACKGROUND
Dillon MT, O'Connell BP, Canfarotta MW, Buss E, Hopfinger J. Effect of Place-Based Versus Default Mapping Procedures on Masked Speech Recognition: Simulations of Cochlear Implant Alone and Electric-Acoustic Stimulation. Am J Audiol. 2022 Jun 2;31(2):322-337. doi: 10.1044/2022_AJA-21-00123. Epub 2022 Apr 8.
PMID: 35394798BACKGROUND
Dalbert A, Weder S. [Application of extra- and intracochlear electrocochleography during and after cochlear implantation]. HNO. 2025 Jan;73(1):14-21. doi: 10.1007/s00106-024-01481-4. Epub 2024 May 18. German.
PMID: 38761228BACKGROUND

Study Officials

Armina Kreuzer, Dr.
Luzerner Kantonsspital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Armina Kreuzer, Dr.

CONTACT

+41 205 50 59 armina.kreuzer@luks.ch

Wai Kong Lai, Dr.

CONTACT

waikong.lai@luks.ch

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Senior Audiologist

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing: Will not share

Optimization and Validation of Electric Acoustic Stimulation (EAS) Mapping as a Function of Residual Hearing After CI-Implantation

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Sequence A, subjective followed by objective fitting

Sequence B, objective followed by subjective fitting

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (9)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Sequence A, subjective followed by objective fitting

Sequence B, objective followed by subjective fitting

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (9)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing