Hearing Loss, Sensorineural
Conditions
Keywords
Cochlear Implant, Hearing Loss, Hearing Aids, Hearing Tests
Brief summary
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods. This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.
Interventions
DEVICECROS
Advanced Bionics CROS
DEVICEHearing Aid
Advanced Bionics Naida hearing aid
OTHERCochlear Implant Alone
No hearing device on contralateral ear
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
\*: * An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience * Low frequency Pure Tone Audiometry (PTA)
Exclusion criteria
\*: * Non-English speakers * Additional Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | 12 minutes | The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes. |
| CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | 12 minutes | The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes. |
| CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | 12 minutes | The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants in crossover study. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Cognition/Memory Concern Cognition/Memory Concern | 3 Participants |
| Cognition/Memory Concern Missing | 1 Participants |
| Cognition/Memory Concern No Concern | 21 Participants |
| Contralateral Ear Device Contralateral Routing of Signal (CROS) device | 1 Participants |
| Contralateral Ear Device Hearing Aid | 19 Participants |
| Contralateral Ear Device Nothing | 5 Participants |
| Daily Use of Implant (hours) | 14.7 hours STANDARD_DEVIATION 3.12 |
| Diagnosis Related to Cognition/Memory Has Diagnosis Related to Cognition/Memory | 2 Participants |
| Diagnosis Related to Cognition/Memory Missing | 1 Participants |
| Diagnosis Related to Cognition/Memory No Diagnosis Related to Cognition/Memory | 22 Participants |
| Ear Protection with Excessive Noise Ear Protection | 3 Participants |
| Ear Protection with Excessive Noise Missing | 14 Participants |
| Ear Protection with Excessive Noise No Ear Protection | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Exposure to Excessive Noise Exposure to Excessive Noise | 11 Participants |
| Exposure to Excessive Noise No Exposure to Excessive Noise | 14 Participants |
| Has Tinnitus No Tinnitus | 10 Participants |
| Has Tinnitus Tinnitus | 14 Participants |
| Has Tinnitus Unknown | 1 Participants |
| Head Trauma Head Trauma | 3 Participants |
| Head Trauma Missing | 1 Participants |
| Head Trauma No Head Trauma | 21 Participants |
| Hearing loss duration (years) | 29.7 years STANDARD_DEVIATION 16.6 |
| Implant Device CII Bionic Ear | 1 Participants |
| Implant Device HiRes 90K | 12 Participants |
| Implant Device HiRes Ultra with HiFocus 1J | 8 Participants |
| Implant Device HiRes Ultra with HiFocus Mid-Scal | 4 Participants |
| Implant Side Left | 9 Participants |
| Implant Side Right | 16 Participants |
| PTA: Cochlear Implant Alone High Frequency PTA | 28.2 dB STANDARD_DEVIATION 4.87 |
| PTA: Cochlear Implant Alone Low Frequency PTA | 31.1 dB STANDARD_DEVIATION 7 |
| PTA: Cochlear Implant Alone PTA (avg 500, 1000, 2000) | 29.5 dB STANDARD_DEVIATION 5.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 13 Participants |
| Tinnitus Ears Both | 8 Participants |
| Tinnitus Ears Left | 1 Participants |
| Tinnitus Ears None/Missing | 11 Participants |
| Tinnitus Ears Not Sure | 3 Participants |
| Tinnitus Ears Right | 2 Participants |
| Tinnitus Frequency Constant | 7 Participants |
| Tinnitus Frequency Intermittent | 6 Participants |
| Tinnitus Frequency Missing | 11 Participants |
| Tinnitus Frequency Not Sure | 1 Participants |
| Unaided Left PTA High Frequency PTA | 99.3 dB STANDARD_DEVIATION 23.5 |
| Unaided Left PTA Low Frequency PTA | 77.0 dB STANDARD_DEVIATION 33.5 |
| Unaided Left PTA PTA (avg 500, 1000, 2000) | 94.0 dB STANDARD_DEVIATION 24.1 |
| Unaided Right PTA High Frequency PTA | 98.8 dB STANDARD_DEVIATION 23.2 |
| Unaided Right PTA Low Frequency PTA | 80.5 dB STANDARD_DEVIATION 28.3 |
| Unaided Right PTA PTA (avg 500, 1000, 2000) | 94.0 dB STANDARD_DEVIATION 23.8 |
| Years since first hearing aid fit | 20.8 years STANDARD_DEVIATION 14.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Time frame: 12 minutes
Population: One participant did not have data collected while wearing the contralateral device. Data is only available for 5 participants in the No Contralateral Device group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Contralateral Device (Cochlear Implant Alone) | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Contra Speech, Ipsi Noise | 12.9 ratio | Standard Deviation 10.3 |
| No Contralateral Device (Cochlear Implant Alone) | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Front Speech, Front Noise | 15.3 ratio | Standard Deviation 6.29 |
| No Contralateral Device (Cochlear Implant Alone) | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Contra Speech, Omni | 9.9 ratio | Standard Deviation 9.96 |
| No Contralateral Device (Cochlear Implant Alone) | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Front Speech, Omni Noise | 10.7 ratio | Standard Deviation 4.65 |
| No Contralateral Device (Cochlear Implant Alone) | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Ipsi Speech, Omni Noise | 9.7 ratio | Standard Deviation 7.17 |
| Cochlear Implant and Contralateral Device | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Front Speech, Omni Noise | 13.5 ratio | Standard Deviation 8.5 |
| Cochlear Implant and Contralateral Device | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Ipsi Speech, Omni Noise | 13.7 ratio | Standard Deviation 8.92 |
| Cochlear Implant and Contralateral Device | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Contra Speech, Ipsi Noise | 16.6 ratio | Standard Deviation 7.65 |
| Cochlear Implant and Contralateral Device | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Contra Speech, Omni | 13.1 ratio | Standard Deviation 8.2 |
| Cochlear Implant and Contralateral Device | CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CICROS, Front Speech, Front Noise | 16.0 ratio | Standard Deviation 7.26 |
Primary
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Time frame: 12 minutes
Population: Data could not be collected for one participant while wearing the Contralateral Device for condition CIHA, Contra Speech, Omni Noise. Data is only available for 5 participants in the No Contralateral Device group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Contralateral Device (Cochlear Implant Alone) | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Contra Speech, Ipsi Noise | 16.4 ratio | Standard Deviation 8.19 |
| No Contralateral Device (Cochlear Implant Alone) | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Front Speech, Front Noise | 14.0 ratio | Standard Deviation 6.78 |
| No Contralateral Device (Cochlear Implant Alone) | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Contra Speech, Omni Noise | 11.6 ratio | Standard Deviation 10.1 |
| No Contralateral Device (Cochlear Implant Alone) | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Front Speech, Omni Noise | 8.65 ratio | Standard Deviation 6.67 |
| No Contralateral Device (Cochlear Implant Alone) | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Ipsi Speech, Omni Noise | 8.62 ratio | Standard Deviation 10.5 |
| Cochlear Implant and Contralateral Device | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Front Speech, Omni Noise | 9.51 ratio | Standard Deviation 7.49 |
| Cochlear Implant and Contralateral Device | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Ipsi Speech, Omni Noise | 9.05 ratio | Standard Deviation 7.06 |
| Cochlear Implant and Contralateral Device | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Contra Speech, Ipsi Noise | 16.9 ratio | Standard Deviation 8.44 |
| Cochlear Implant and Contralateral Device | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Contra Speech, Omni Noise | 11.5 ratio | Standard Deviation 8.17 |
| Cochlear Implant and Contralateral Device | CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CIHA, Front Speech, Front Noise | 14.6 ratio | Standard Deviation 6.62 |
Primary
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Time frame: 12 minutes
Population: One participant did not have data collected while wearing the contralateral device. Data is only available for 5 participants in the No Contralateral Device group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Contralateral Device (Cochlear Implant Alone) | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Ipsi Speech, Omni Noise | 8.45 ratio | Standard Deviation 11.4 |
| No Contralateral Device (Cochlear Implant Alone) | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Contra Speech, Ipsi Noise | 21.2 ratio | Standard Deviation 6.99 |
| No Contralateral Device (Cochlear Implant Alone) | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Contra Speech, Omni Noise | 15.5 ratio | Standard Deviation 8.85 |
| No Contralateral Device (Cochlear Implant Alone) | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Front Speech, Front Noise | 15.8 ratio | Standard Deviation 7.04 |
| No Contralateral Device (Cochlear Implant Alone) | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Front Speech, Omni Noise | 8.85 ratio | Standard Deviation 5.95 |
| Cochlear Implant and Contralateral Device | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Front Speech, Omni Noise | 12.6 ratio | Standard Deviation 8.27 |
| Cochlear Implant and Contralateral Device | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Front Speech, Front Noise | 17.1 ratio | Standard Deviation 6.94 |
| Cochlear Implant and Contralateral Device | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Contra Speech, Ipsi Noise | 22.2 ratio | Standard Deviation 6.17 |
| Cochlear Implant and Contralateral Device | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Ipsi Speech, Omni Noise | 10.4 ratio | Standard Deviation 9.5 |
| Cochlear Implant and Contralateral Device | Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. | CI, Contra Speech, Omni Noise | 15.9 ratio | Standard Deviation 7.73 |