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Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes.

ABSTRACT: The concept of expanding electrical speech processing to those with more residual acoustic hearing with a less-invasive shorter cochlear implant (CI) has been ongoing since 1999. A multicenter study of the Nucleus Hybrid S8 CI took place between 2002 and 2011. This report describes the final outcomes of this clinical trial.Multicenter, longitudinal, single-subject design.Eighty-seven subjects received a Nucleus Hybrid S8 CI in their poorer ear. Speech perception in quiet (Consonant-Nucleus-Consonant [CNC] words) and in noise (Bamford-Kowal-Bench Sentences-In-Noise [BKB-SIN]) were collected pre- and postoperatively at 3, 6, and 12 months. Subjective questionnaire data using the Abbreviated Profile for Hearing Aid Benefit (APHAB) were also collected.Some level of hearing preservation was accomplished in 98% subjects, with 90% maintaining a functional low-frequency pure-tone average (LFPTA) at initial activation. By 12 months, five subjects had total hearing loss, and 80% of subjects maintained functional hearing. CNC words demonstrated that 82.5% and 87.5% of subjects had significant improvements in the hybrid and combined conditions, respectively. The majority had improvements with BKB-SIN. Results also indicated that as long as subjects maintained at least a severe LFPTA, there was significant improvement in speech understanding. Furthermore, all subjects reported positive improvements in hearing in three of the four subscales of the APHAB.The concept of hybrid speech processing has significant advantages for subjects with residual low-frequency hearing. In this study, the Nucleus Hybrid S8 provided improved word understanding in quiet and noise. Additionally, there appears to be stability of the residual hearing after initial activation of the device.2c.

SUBMITTER: Gantz BJ

PROVIDER: S-EPMC4803613 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes.

Gantz Bruce J BJ Dunn Camille C Oleson Jacob J Hansen Marlan M Parkinson Aaron A Turner Christopher C

The Laryngoscope 20160112 4

<h4>Objectives/hypothesis</h4>The concept of expanding electrical speech processing to those with more residual acoustic hearing with a less-invasive shorter cochlear implant (CI) has been ongoing since 1999. A multicenter study of the Nucleus Hybrid S8 CI took place between 2002 and 2011. This report describes the final outcomes of this clinical trial.<h4>Study design</h4>Multicenter, longitudinal, single-subject design.<h4>Methods</h4>Eighty-seven subjects received a Nucleus Hybrid S8 CI in th ...[more]

PMID: 26756395

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Project description:IntroductionOnly a small percentage (6-10%) of patients who are candidates receive cochlear implants (CIs). One potential reason contributing to low usage rates may be confusion regarding which patients to refer for CI evaluation. The extent to which information provided by standard clinical audiologic assessments is sufficient for selecting appropriate CI evaluation referrals is uncertain. The objective of this study is to evaluate the capacity of standard clinical audiologic measures to differentiate CI candidates from noncandidates.MethodThe study design is a retrospective review of a prospectively maintained CI database from a university-based tertiary medical center of 518 patients undergoing CI evaluations from 2012 to 2020. Each ear of each patient was treated as an independent value. Receiver operating characteristic (ROCs) curves were constructed using aided AzBio sentence recognition scores in quiet and aided AzBio +10 dB signal-to-noise ratio scores <60% as binary classifiers for CI candidacy. For each ROC, we examined the capacity of multiple pure-tone thresholds, pure-tone average (PTA), and CNC word recognition scores (WRSs) measured under earphones to determine CI candidacy. Area under the curve ROC (AUC-ROC) values were calculated to demonstrate the capacity of each model to differentiate CI candidates from noncandidates.ResultsVariables with the greatest capacity to accurately differentiate CI candidates from noncandidates using aided AzBio in quiet scores were earphone CNC WRS, earphone pure-tone threshold at 1,000 Hz, and earphone PTA (AUC-ROC values = 0.86-0.88). Using aided AzBio +10 scores as the measure for candidacy, only CNC word recognition had a fair capacity to identify candidates (AUC-ROC value = 0.73). Based on the ROCs, a 1,000 Hz pure-tone threshold >50 dB HL, PTA >57 dB HL, and a monosyllabic WRS <60% can each serve as individual indicators for referral for CI evaluations.ConclusionThe current study provides initial indicators for referral and a first step at developing evidence-based criteria for CI evaluation referral using standard audiologic assessments.

Project description:Aim:To compare implant survival rate and marginal bone loss (MBL) of immediately loaded single implants inserted by using ultrasonic implant site preparation (UISP) (test) and conventional rotary instrumentation (control). Methods:Two single implants were inserted for each patient: after randomization, test site was prepared by using an ultrasonic device (Piezosurgery Touch, Mectron, Italy) and control site was prepared by using the drills of the selected implant system (Premium AZT, Sweden & Martina, Italy), until reaching a final diameter of 3?mm in both groups. Identical implants (3.8x11.5?mm) were inserted in all sites at crestal level. Impressions were taken and screwed resin single crowns with platform-switched provisional abutments were delivered with 48 hours. Periapical radiographs were taken at provisional crown insertion (T0), 6 months (T1) and one year (T2) after prosthetic loading to measure MBL. All data were tested for normality and subsequently analyzed by paired samples t-test and forward multiple linear regression. Results:Forty-eight patients were treated in six centers with the insertion of ninety-six implants (48 test; 48 control). Four implants in four patients failed within the first six months of healing (two in test group; two in control group; no difference between groups). Forty patients (age 60.1±10.7 years; 22 female, 18 male) were included in the final analysis. Mean MBL after six months of loading was 1.39±1.03?mm in the test group and 1.42±1.16?mm in the control group (p>0.05) and after one year was 1.92±1.14?mm and 2.14±1.55?mm in test and control, respectively (p>0.05). Conclusions:No differences in survival rate and MBL were demonstrated between UISP and conventional site preparation with rotary instruments in immediately loaded dental implants: UISP, with its characteristics of enhanced surgical control and safety in proximity of delicate structures, may be used as a reliable alternative to the traditional drilling systems.

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Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes.

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Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes.

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