Fitting Methods by EAS PatientsNCT07476079
Optimization and Validation of Electric Acoustic Stimulation (EAS) Mapping as a Function of Residual Hearing After CI-Implantation
A study testing The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study. and The subjective adjustment of an EAS based on thresholds from the pure tone audiogram. in people with Fitting Methods by EAS Patients, run by Luzerner Kantonsspital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fitting Methods by EAS Patients
- What is being tested?
- The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study. and The subjective adjustment of an EAS based on thresholds from the pure tone audiogram.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Wai Kong Lai, Dr. contact
About this study
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.
Read the detailed description
As the indications for Cochlear Implant (CI) Surgery expand to also include hearing impaired patients with some residual hearing in the ipsilateral (to be implanted) ear, residual hearing preservation during the surgical intervention becomes even more important. It is also known from the literature that patients will benefit from having good residual acoustic hearing after CI-Implantation in terms of the sound quality. This is particularly so for speech comprehension in noise as well as for music perception with the CI.
Present-day clinical Sound Processor programming software provides Electric Acoustic Stimulation (EAS) to account for preserved residual hearing. For an optimized EAS fitting, it is postulated here that optimal conditions are achieved when the electric and acoustic stimulation do not overlap. To achieve this, the acoustic stimulation ought to be limited to only regions where there is still useful acoustic hearing, while the electric stimulation should also be restricted to regions where there is no longer significant useful acoustic hearing. In the Maestro clinical software, the threshold for significant useful acoustic hearing is set to 65 dB Hearing Level (HL). This then determines the cut-off frequency between the acoustic and electric stimulation regions.
The standard clinical Maestro software computes this cut-off based on a regular pure tone audiogram (PTA) which has been manually stored in the software. However, it is arguable that this does not always represent an accurate cut-off frequency required for optimal fitting because the audiogram thresholds themselves are subjective in nature and can often vary in a test-retest situation, depending on the attention and reaction times of the patient. It has been reported that the unaided thresholds do not play a significant role in the EAS fitting. In this respect, it may be more accurate and beneficial to use objective measures such as electrocochleography (ECochG) to determine the thresholds of the residual hearing.
The current family of Med-El Cochlear Implants are equipped with the capability to perform ECochG measurements using the implant's own intracochlear electrodes within the scala tympani. The measurements can also be conducted intraoperatively or postoperatively. This intracochlear ECochG feature of the implants therefore allows us to objectively determine the residual hearing thresholds.
The aim of this study is to discuss the advantages of objective fitting of the EAS compared to subjective fitting using a PTA with respect to speech intelligibility in quiet and in 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.
From the existing literature, it is not expected that there should be any significant gender effects. This also does not belong to the primary aims of this study and we will not be investigating this aspect.
- Conditions
- Fitting Methods by EAS Patients
- Being tested
- The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study., The subjective adjustment of an EAS based on thresholds from the pure tone audiogram.
- Keywords
- Cochlear Implant patients, Residual hearing in the low frequency range, EAS, fitting methods, electrocochleography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months after EAS fitting
Secondary outcomes (3)
Subjective level of auditory benefit
A secondary outcome measure is subjective level of auditory benefit at three months after EAS fitting (either objective or subjective EAS fitting in a cross-over design), as determined using the HISQUI-19 (Hearing Implant Sound Quality Index) questionnaire.
Measured: Three months after EAS fitting
Subjectively preferred EAS fitting method
The subjectively preferred EAS fitting method at the end of the study will be examined.
Measured: at the end of the study, six months after baseline
Post-operative ECochG and PTA tresholds
Post-operative ECochG and PTA thresholds at three months after EAS fitting (either objective or subjective EAS fitting in a cross-over design).
Measured: Three months after EAS fitting (either objective or subjective EAS fitting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fitting Methods by EAS PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Responsible party
- Principal investigator, Armina Kreuzer, Luzerner Kantonsspital
- Investigators
- Armina Kreuzer, Dr., Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476079
- Sponsor's protocol ID
- EAS_fitting
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33426931Rajan 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.
PubMed 2907384415. 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.
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.
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.
PubMed 34401506Gifford 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.
PubMed 35985964Gawliczek 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.
PubMed 37745650Dillon 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.
PubMed 35394798Dalbert 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.
PubMed 38761228
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Validation of Electric Acoustic Stimulation (EAS) Mapping as a Function of Residual Hearing After CI-Implantation
- ClinicalTrials.gov ID
- NCT07476079
- Acronym / sponsor ID
- EAS_fitting
- Conditions
- Fitting Methods by EAS Patients
- Keywords
- Cochlear Implant patients, Residual hearing in the low frequency range, EAS, fitting methods, electrocochleography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As the indications for Cochlear Implant (CI) Surgery expand to also include hearing impaired patients with some residual hearing in the ipsilateral (to be implanted) ear, residual hearing preservation during the surgical intervention becomes even more important. It is also known from the literature that patients will benefit from having good residual acoustic hearing after CI-Implantation in terms of the sound quality. This is particularly so for speech comprehension in noise as well as for music perception with the CI.
Present-day clinical Sound Processor programming software provides Electric Acoustic Stimulation (EAS) to account for preserved residual hearing. For an optimized EAS fitting, it is postulated here that optimal conditions are achieved when the electric and acoustic stimulation do not overlap. To achieve this, the acoustic stimulation ought to be limited to only regions where there is still useful acoustic hearing, while the electric stimulation should also be restricted to regions where there is no longer significant useful acoustic hearing. In the Maestro clinical software, the threshold for significant useful acoustic hearing is set to 65 dB Hearing Level (HL). This then determines the cut-off frequency between the acoustic and electric stimulation regions.
The standard clinical Maestro software computes this cut-off based on a regular pure tone audiogram (PTA) which has been manually stored in the software. However, it is arguable that this does not always represent an accurate cut-off frequency required for optimal fitting because the audiogram thresholds themselves are subjective in nature and can often vary in a test-retest situation, depending on the attention and reaction times of the patient. It has been reported that the unaided thresholds do not play a significant role in the EAS fitting. In this respect, it may be more accurate and beneficial to use objective measures such as electrocochleography (ECochG) to determine the thresholds of the residual hearing.
The current family of Med-El Cochlear Implants are equipped with the capability to perform ECochG measurements using the implant's own intracochlear electrodes within the scala tympani. The measurements can also be conducted intraoperatively or postoperatively. This intracochlear ECochG feature of the implants therefore allows us to objectively determine the residual hearing thresholds.
The aim of this study is to discuss the advantages of objective fitting of the EAS compared to subjective fitting using a PTA with respect to speech intelligibility in quiet and in 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.
From the existing literature, it is not expected that there should be any significant gender effects. This also does not belong to the primary aims of this study and we will not be investigating this aspect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A, subjective followed by objective fitting | Other | 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.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. |
| Sequence B, objective followed by subjective fitting | Other | 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.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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study.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. | Other | Sequence A, subjective followed by objective fitting, Sequence B, objective followed by subjective fitting |
| The subjective adjustment of an EAS based on thresholds from the pure tone audiogram.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. | Other | Sequence A, subjective followed by objective fitting, Sequence B, objective followed by subjective fitting |
Primary outcome
Speech Recognition Threshold (SRT50)
Time frame: Three months after EAS fitting
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.
3 secondary outcomes
Subjective level of auditory benefit
Time frame: Three months after EAS fitting
Subjectively preferred EAS fitting method
Time frame: at the end of the study, six months after baseline
Post-operative ECochG and PTA tresholds
Time frame: Three months after EAS fitting (either objective or subjective EAS fitting)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 33426931Schaefer 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.
- Background: PubMed 29073844Rajan 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.
- Background15. 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.
- BackgroundWagener 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: PubMed 34401506Hey 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.
- Background: PubMed 35985964Gifford 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.
- Background: PubMed 37745650Gawliczek 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.
- Background: PubMed 35394798Dillon 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.
- Background: PubMed 38761228Dalbert 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: 38761228Link provided by the sponsor.
- PMID: 35394798Link provided by the sponsor.
- PMID: 37745650Link provided by the sponsor.
- PMID: 35985964Link provided by the sponsor.
- PMID: 34401506Link provided by the sponsor.
- Google ScholarLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wai Kong Lai, Dr. contact
Armina Kreuzer, Dr. principal investigator
Luzerner Kantonsspital
Questions about this trial
What is this clinical trial studying?
A study testing The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study. and The subjective adjustment of an EAS based on thresholds from the pure tone audiogram. in people with Fitting Methods by EAS Patients, run by Luzerner Kantonsspital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armina Kreuzer, Dr. (+41 205 50 59, armina.kreuzer@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Recognition Threshold (SRT50) (time frame: Three months after EAS fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07476079, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.