Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In search of the best possible outcome for the severe hearing impaired who have regained the ability to hear by means of a cochlear implant (CI), electrical stimulation and the information it carries should match as closely as possible to what the human brain naturally has evolved to cope with and learned to process instead of relying on plasticity to adapt to an induced mismatch. At the moment, however, CI's are fitted with a 'one size fits all' principle. This is known to cause a mismatch between the frequencies presented by the CI electrode array and the frequencies represented at the corresponding natural acoustic location in an individual cochlea. In this study it is hypothesized that an individual imaged based fitting that pursues natural hearing alignment and is implemented from the start of the rehabilitation process, will improve the individual outcomes of electric hearing. The natural fitting strategy is thought to give rise to a steeper learning curve, result in a better performance in challenging listening situations, improve sound quality, complement better with residual acoustic hearing in the contralateral ear and win the preference of CI-recipients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaged based fitting | Experimental | Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods. |
|
| Clinical routine | No Intervention | Mapping of the electrical input of the cochlear implant will be based on a one-size-fits-all, as is part of clinical routine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaged based fitting | Device | Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech understanding in quiet with cochlear implant | Speech understanding with CI in quiet measured with the Dutch Consonant Nucleus Consonant (CNC) test. | During the first 12 months of CI rehabilitation |
| Speech understanding in quiet with cochlear implant | Speech understanding with CI in quiet will be measured with the Dutch Matrix sentence test. | During the first 12 months of CI rehabilitation |
| Speech understanding in noise with cochlear implant | Speech understanding with CI in noise will be measured with the Dutch Matrix sentence test. | During the first 12 months of CI rehabilitation |
| Patient preference | At every fitting session, patients will be asked to rate their satisfaction with either the control or experimental program on a 10-point Visual Analog Sscale (1 dissatisfied - 10 very satisfied). | During the first 12 months of CI rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| Speech understanding with hearing aid | Speech understanding with hearing aid will be measured with the Dutch Consonant Nucleus Consonant (CNC) test. | During the first 12 months of CI rehabilitation |
| Speech understanding with hearing aid |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Lambriks, Drs. | Contact | 0636166071 | lars.lambriks@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Erwin George, Dr. | Maastricht UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUMC | Recruiting | Maastricht | Limburg | 6202 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32576247 | Derived | Lambriks LJG, van Hoof M, Debruyne JA, Janssen M, Chalupper J, van der Heijden KA, Hof JR, Hellingman CA, George ELJ, Devocht EMJ. Evaluating hearing performance with cochlear implants within the same patient using daily randomization and imaging-based fitting - The ELEPHANT study. Trials. 2020 Jun 23;21(1):564. doi: 10.1186/s13063-020-04469-x. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003638 | Deafness |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Speech understanding with hearing aid will be measured with the Dutch Matrix sentence test.
| During the first 12 months of CI rehabilitation |
| Spatial masking | The Spatial Speech Perception In Noise (SSPIN) test will be used to determine the head shadow and squelch effect [74]. | During the first 12 months of CI rehabilitation |
| Listening effort | In a listening effort test subjects are asked to rate the effort it takes to listen to speech fragments in noise.The listening effort test is based on subjective ratings for the ease or difficulty involved in listening to speech in the presence of varying amounts of noise. Speech and noise are presented from the same loudspeaker in front of the subject. Three relevant signal-to noise ratios will be tested repeatedly (5 times) and the mean effort level will be calculated. Rating is performed using a vertical scale with 13 discrete points (seven named categories interspersed with an empty category) ranging from no effort (Score 0) to extreme effort (Score 12). | During the first 12 months of CI rehabilitation |
| Spectral resolution (SMRT test) | The ability to spectrally resolve frequency information is known to be related to speech understanding performance (in noise). Frequency selectivity will be monitored to test the ability of the patient to filter out one stimulus from the others on the basis of frequency. This will be done with the Spectral-temporally Modulated Ripple Test (SMRT). | During the first 12 months of CI rehabilitation |
| Loudness scaling (ACALOS test) | To estimate the course of loudness percept between minimal audible level and maximum comfortable level, a procedure is used that automatically adjusts the presentation levels to the subject's individual auditory dynamic range without employing any pre-measurement. The procedure uses repeated measurements and presents levels in randomized order. It has been named "ACALOS" (Adaptive Categorical LOudness Scaling). Results will provide information about the difference in loudness percept between CI and HA and will give input for optimizing the fitting of these hearing devices across the dynamic range. | During the first 12 months of CI rehabilitation |
| Telemetric data | By measuring Evoked Compound Action Potential (ECAP), telemetric data on the function of the implant and the response of the auditory nerve will be collected. | During the first 12 months of CI rehabilitation |
| Quality of life in relation to hearing ability. | Measured with the Speech-Spatial-Qualities (SSQ) questionnaire. A short form of the SSQ (SSQ-12) will be used. The SSQ is designed for use typically as a complement to behavioural or experimental measures of hearing ability and consists of questions on the following domains: speech hearing, spatial hearing, qualities of hearing, and listening effort. Participants will be asked to answer 12 questions on a 10-point Visual Analogue Scale with different units. | During the first 12 months of CI rehabilitation |
| Overall wellbeing | Measured with the ICEpop CAPability measure for adults (ICECAP-A) | During the first 12 months of CI rehabilitation |
| Overall Quality of life | Measured with the Health Utility Index Mark 3 (HUI-3) | During the first 12 months of CI rehabilitation |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |