Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet |
Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.) |
Pre-implant and 6 months post-implant |
|
| Primary |
Change in Poor Ear Alone Soundfield Thresholds |
Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Sound Localization |
Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) |
Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) |
Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear |
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone |
Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Hearing Handicap Inventory (HHIE) |
Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Health Utility Index (HUI3) Ratings |
Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant |
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant |
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) |
Pre-implant and 12 months post-implant |
|
| Secondary |
Change in Satisfaction With Amplification in Daily Use (SADL) |
Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) |
The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant |
Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.) |
Pre-implant and 6 months post-implant |
|
| Secondary |
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear |
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) |
Pre-implant and 6 months post-implant |
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