Cochlear ImplantNCT05360212
Anatomy-based Fitting in Cochear Implant Users
A study testing Anatomy-based fitting (ABF), Standard Fitting and Standard fitting+ ABF in people with Cochlear Implant and Outcomes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
Trial summary
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implant, Outcomes, Quality of Life
- What is being tested?
- Anatomy-based fitting (ABF), Standard Fitting and Standard fitting+ ABF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2022to 31 Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- Post-OP CT scan of the CI electrode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex28 or FlexSoft electrode
- Subject planned to receive a SONNET 2 /RONDO3 audio processor on the newly implanted side
Show all 17Show fewer
- Audio processor not yet activated on the newly implanted side
- The most apical active electrode contact has to be inserted at least 450°
- Minimum of 10 active channels can be activated
- Fluent in Spanish
- Signed and dated ICF before the start of any study-specific procedure
- Specific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2/RONDO3 audio processor on the first ear implanted
- 40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side
- 40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion
- Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)
- SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB
- Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB
Who cannot join
- Lack of compliance with any inclusion criteria
- EAS user (user of an EAS audio processor)
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- Known allergic reactions to components of the investigational medical device
- Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de La Paz
Madrid, Madrid, 28046
Miryam Calvino, miryamcf@yahoo.com
About this study
Official title: Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.
Read the detailed description
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9. The performance with anatomy-based fitting is assessed by comparing performance with the CI in these two groups over time.
The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.
- Conditions
- Cochlear Implant, Outcomes, Quality of Life
- Being tested
- Anatomy-based fitting (ABF), Standard Fitting, Standard fitting+ ABF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomy-based fitting (ABF)Procedure or surgery
MAESTRO 9 can display the tonotopic frequency of each individual electrode channel imported from OTOPLAN to further support fitting based on these measures. The audiologist can set a frequency-band distribution that is more closely aligned to the tonotopic frequency distribution as imported from OTOPLAN.
Standard FittingProcedure or surgery
These group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9.
Standard fitting+ ABFProcedure or surgery
Patients of this group are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.
| Study group | Role | What they receive |
|---|---|---|
| Standard fitting | Placebo comparator | The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 Receives: Procedure: Standard Fitting |
| Anatomy-based fitting | Experimental | In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9 Receives: Procedure: Anatomy-based fitting (ABF) |
| Within-subject design: Standard fitting + ABF | Experimental | The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Receives: Procedure: Standard fitting+ ABF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result from the speech test in noise (S0N0)
Speech perception evaluation with CI-only (MATRIX) with signal and noise in the same channel
Measured: Month 6
Results from speech tests in noise with spatially separated loudspeakers
Speech perception evaluation with CI-only (MATRIX) with signal and noise in different channels
Measured: Month 6
Result from the speech test in quiet (S0)
Speech perception evaluation with CI-only (disyllables)
Measured: Month 6
Secondary outcomes (2)
Results of quality of sound
Subjective results through Hearing Implant Sound Quality Index 19. Scores range 19-133 points. Higher scores mean a better outcome.
Measured: Month 6
Results of quality of life in challenging situations
Subjective results through Listening effort questionnaire. Scores range 21-93 points. Higher scores mean a better outcome.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start11 Mar 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Sponsor type
- University, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Responsible party
- Principal investigator, Luis Lassaletta, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Investigators
- Luis Lassaletta, PhD, Principal investigator, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360212
- Sponsor's protocol ID
- PI-6128
- Status last verified
- Feb 2025
- First submitted
- 23 Apr 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.
- ClinicalTrials.gov ID
- NCT05360212
- Acronym / sponsor ID
- PI-6128
- Conditions
- Cochlear Implant, Outcomes, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la PazUniversity, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 May 2022 (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.
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.
Detailed description
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9. The performance with anatomy-based fitting is assessed by comparing performance with the CI in these two groups over time.
The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard fitting | Placebo comparator | Procedure: Standard FittingThe first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 |
| Anatomy-based fitting | Experimental | Procedure: Anatomy-based fitting (ABF)In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9 |
| Within-subject design: Standard fitting + ABF | Experimental | Procedure: Standard fitting+ ABFThe third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- Post-OP CT scan of the CI electrode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex28 or FlexSoft electrode
Key exclusion criteria (6 listed)
- Lack of compliance with any inclusion criteria
- EAS user (user of an EAS audio processor)
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- Known allergic reactions to components of the investigational medical device
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 |
|---|---|---|
| Anatomy-based fitting (ABF)MAESTRO 9 can display the tonotopic frequency of each individual electrode channel imported from OTOPLAN to further support fitting based on these measures. The audiologist can set a frequency-band distribution that is more closely aligned to the tonotopic frequency distribution as imported from OTOPLAN. | Procedure or surgery | Anatomy-based fitting |
| Standard FittingThese group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. | Procedure or surgery | Standard fitting |
| Standard fitting+ ABFPatients of this group are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting. | Procedure or surgery | Within-subject design: Standard fitting + ABF |
Primary outcome
Result from the speech test in noise (S0N0)
Time frame: Month 6
Speech perception evaluation with CI-only (MATRIX) with signal and noise in the same channel
Results from speech tests in noise with spatially separated loudspeakers
Time frame: Month 6
Speech perception evaluation with CI-only (MATRIX) with signal and noise in different channels
Result from the speech test in quiet (S0)
Time frame: Month 6
Speech perception evaluation with CI-only (disyllables)
2 secondary outcomes
Results of quality of sound
Time frame: Month 6
Results of quality of life in challenging situations
Time frame: Month 6
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 12 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant
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An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
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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.
Luis Lassaletta, PhD principal investigator
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomy-based fitting (ABF), Standard Fitting and Standard fitting+ ABF in people with Cochlear Implant and Outcomes, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
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 17 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Luis Lassaletta, PhD (0034656898265, llasaletta@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result from the speech test in noise (S0N0) (time frame: Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.