Objectives/Hypothesis
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.
Study Design
Multicenter, longitudinal, single‐subject design.
Methods
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.
Results
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.
Conclusions
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.
Level of Evidence
2c Laryngoscope, 126:962–973, 2016
•Hearing preservation cochlear implant outcomes review.•Benefits of preserving low-frequency residual hearing during cochlear implantation.•Cochlear implant clinical trial summaries on hearing ...preservation.•Preservation of residual hearing improves hearing in noise, melody recognition and spatial hearing.
Preservation of residual acoustic hearing has emerged as an important concept for those individuals undergoing cochlear implantation with residual low frequency hearing. Acoustic plus electric speech processing improves hearing outcomes in quiet, enables melody recognition, preserves spatial hearing if there is acoustic hearing in both ears and significantly improves hearing in noise. The development of our experience with acoustic plus electric processing is reviewed along with clinical trials and patient outcomes that our team has documented over the past twenty years.
Objective
To demonstrate the long‐term benefits of implantation in patients with high‐frequency sensorineural hearing loss, this report provides 5‐year follow‐up on a group of implant recipients who ...were subjects of the Cochlear™ Nucleus® Hybrid™ L24 Implant System pivotal clinical study.
Methods
The results of three related clinical studies were compiled to provide outcome data after 1, 3, and 5 years of implant use in a group of subjects who presented with preoperative high‐frequency hearing loss and were implanted with a Nucleus Hybrid L24 (Cochlear Ltd., Sydney, Australia) cochlear implant. A subset of the 50 adult subjects (N = 32) who participated in the Hybrid L24 pivotal Investigational Device Exemption (IDE) completed comprehensive evaluations at 12 months postactivation, 3 years postactivation, and then as part of a postapproval study at 5 years postactivation. Testing included audiometric, speech perception, and subjective satisfaction measures.
Results
Mean unilateral speech perception performance was significantly improved at all postoperative intervals compared to preoperative best‐aided results and has remained stable to 5 years postactivation. Ninety‐four percent of subjects had measurable hearing, and 72% continued to use electric‐acoustic stimulation in the implanted ear after 5 years of implant use. Subjective satisfaction results support objective performance improvements.
Conclusion
Results demonstrate long‐term success of patients with high‐frequency hearing loss following Hybrid L24 (Cochlear) cochlear implantation. Benefits include speech perception abilities significantly better than those in the preoperative best‐aided condition, with additional benefit in those using electric‐acoustic stimulation in the implanted ear.
Level of Evidence
2b. Laryngoscope, 1939–1945, 2018
To evaluate the safety and utility of an investigational robotic-assisted cochlear implant insertion system.
Prospective, single-arm, open-label study under abbreviated Investigational Device ...Exemption requirements.
All procedures were performed, and all data were collected, at a single tertiary referral center.
Twenty-one postlingually deafened adult subjects that met Food and Drug Administration indication criteria for cochlear implantation.
All patients underwent standard-of-care surgery for unilateral cochlear implantation with the addition of a single-use robotic-assisted insertion device during cochlear electrode insertion.
Successful insertion of cochlear implant electrode array, electrode array insertion time, postoperative implant function.
Successful robotic-assisted insertion of lateral wall cochlear implant electrode arrays was achieved in 20 (95.2%) of 21 patients. One insertion was unable to be achieved by either robotic-assisted or manual insertion methods, and the patient was retrospectively found to have a preexisting cochlear fracture. Mean intracochlear electrode array insertion time was 3 minutes 15 seconds. All implants with successful robotic-assisted electrode array insertion (n = 20) had normal impedance and neural response telemetry measures for up to 6 months after surgery.
Here we report the first human trial of a single-use robotic-assisted surgical device for cochlear implant electrode array insertion. This device successfully and safely inserted lateral wall cochlear implant electrode arrays from the three device manufacturers with devices approved but he Food and Drug Administration.
To determine the national rates of spontaneous CSF leaks and to determine the association with risk factors.
Retrospective review from 2002 to 2012.
University HealthSystem Consortium (UHC) database ...of 127 of the leading academic medical centers in the United States (81 centers participated all years of the study).
Those who underwent craniotomy for CSF leak repair in the UHC database and those who have undergone repair of spontaneous CSF leaks at one UHC center.
Assessment of procedure code rates and patient demographics from 2002 to 2012.
National rates of craniotomy for spontaneous CSF leak repair each year, the relation to U.S. regional obesity rates, and the proportion of patients with coincident obstructive sleep apnea. Spontaneous CSF leak patient characteristics (age, sex, BMI, hypertension, and OSA) were calculated.
The rate of craniotomy for spontaneous CSF leak repair has risen 2 fold from 2002 (218 cases per year) to 2012 (488 cases per year). There was no change in the rate of nonspontaneous CSF leaks over the same period. The rate of spontaneous CSF leak repair is twice as high (2.54 versus 1.07 per million people per year) in regions of the United States with the highest obesity rate (Midwest) compared with the lowest obesity rate (West). All patients with spontaneous CSF leaks were overweight (BMI, >25 kg/m2) with an average BMI of 37.8 kg/m2. The average age was 57.03 years, and 72% were female. Patients with spontaneous CSF leaks presented with high rate of OSA (14.8% nationally and 37.1% at the University of Iowa) and hypertension (85.7%).
The national rate of craniotomy for spontaneous CSF leak repair is rising. This condition is yet another public health problem related to the rising obesity epidemic. All patients with spontaneous CSF leaks should be evaluated for OSA.
Objectives/Hypothesis
To evaluate the safety and efficacy of acoustic and electric sound processing for individuals with significant residual low‐frequency hearing and severe‐to‐profound ...high‐frequency sensorineural hearing loss.
Study Design
Prospective, single‐arm repeated measures, single‐subject design.
Methods
Fifty individuals, ≥ 18 years old, with low‐frequency hearing and severe high‐frequency loss were implanted with the Cochlear Nucleus Hybrid L24 implant at 10 investigational sites. Preoperatively, subjects demonstrated consonant‐nucleus‐consonant word scores of 10% through 60% in the ear to be implanted. Subjects were assessed prospectively, preoperatively, and postoperatively on coprimary endpoints of consonant‐nucleus‐consonant words, AzBio sentences in noise, and self‐assessment measures.
Results
Significant mean improvements were observed for coprimary endpoints: consonant‐nucleus‐consonant words (35.8 percentage points) and AzBio sentences in noise (32.0 percentage points), both at P < 0.001. Ninety‐six percent of subjects performed equal or better on speech in quiet and 90% in noise. Eighty‐two percent of subjects showed improved performance on speech in quiet and 74% in noise. Self‐assessments were positive, corroborating speech perception results.
Conclusion
The Nucleus Hybrid System provides significant improvements in speech intelligibility in quiet and noise for individuals with severe high‐frequency loss and some low‐frequency hearing. This device expands indications to hearing‐impaired individuals who perform poorly with amplification due to bilateral high‐frequency hearing loss and who previously were not implant candidates.
Level of Evidence
2b. Laryngoscope, 126:175–181, 2016
Objective
Few studies have investigated the stability of residual hearing and speech perception outcomes in individuals who were implanted with a shorter electrode device.
Study Design
Longitudinal, ...single‐subject design.
Methods
Fifty subjects who received a Nucleus Hybrid (Cochlear, Sydney, Australia) short electrode cochlear implant (CI) and had a minimum of 2 years (and up to 15 years) of postoperative longitudinal experience were included in this study. Twenty‐three subjects received a Nucleus Hybrid S8 (S8); 14 subjects received a Nucleus Hybrid L24 (L24); and 13 received a Nucleus Hybrid S12 (S12). Audiometric thresholds and consonant‐nucleus‐consonant (CNC) words were collected pre‐ and postoperatively for up to 15 years for the S8 subjects and for up to 7 years for the S12 and L24 subjects. AzBio Sentences in multi‐talker babble was collected for up to 7 years on the S12 and L24 subjects.
Results
Longitudinally, 83% of the S8 subjects, 92% of the S12 subjects, and 86% of the L24 subjects maintained a functional hearing pure‐tone average (PTA) (125–500 Hz). Predicted change using a piecewise linear mixed model in PTA over time showed a postoperative linear decrease in hearing for each group until 0.5 years, after which the PTA stabilizes and is maintained. The averaged individual data for CNC and AzBio sentences show a significant improvement in scores by 0.25 to 0.5 years postimplantation, after which scores start to reach their maximum.
Conclusion
This long‐term study demonstrates that acoustic‐electric processing hearing and improvement in speech understanding in quiet and in noise can be accomplished and sustained for many years with a short electrode CI.
Level of Evidence
2C. Laryngoscope, 128:473–481, 2018
Objectives/Hypothesis: The concept of combining electrical stimulation for high‐frequency sound with acoustic hearing for low‐frequency information was tested. In addition, whether residual hearing ...can be preserved when an electrode is placed into the inner ear up to 10 mm and whether place of electrical stimulation influences speech perception were tested. Study Design: A single‐subject clinical trial design was employed. Methods: Six postlingual adults with severe high‐frequency hearing impairment were recruited to participate in the study. A new six‐channel cochlear implant was designed for the clinical trial. The intracochlear electrodes were either 6 or 10 mm in length based on a Nucleus CI‐24 multichannel implant. Monosyllabic word understanding and consonant identification testing in a recorded sound‐only condition were used to assess changes in speech perception. Follow‐up was greater than 12 months. Results: Acoustic hearing was preserved in all six subjects (n = 3,6‐mm electrodes; n = 3,10‐mm electrodes). Preoperative monosyllabic word and sentence scores were unchanged in all subjects following implantation. A 30% to 40% improvement in consonant recognition occurred with the 10‐mm electrode. The subjects with 10‐mm electrodes were able to understand 83% to 90% of the monosyllabic words using the implant plus binaural hearing aids. Scores were more than doubled when compared with preoperative scores with hearing aids only. Conclusion: The human ear has the capability to integrate both acoustic and high‐frequency electrically processed speech information. Placement of a short, 10‐mm electrode does not appear to damage residual low‐frequency inner ear hair cell function, interfere with the micro mechanics of normal cochlear vibration, or decrease residual speech perception. The improvement in speech recognition was due primarily to the increased perception of higher‐frequency consonantal speech cues, and this improvement took several months to become apparent. Such a device can provide a substantial benefit in speech understanding to individuals with severe high‐frequency hearing loss, while still maintaining the benefits of the residual lower‐frequency acoustic hearing. The position of the electrode and the place of frequency information within the cochlea were shown to be important factors in the success of such a device.
Objectives/Hypothesis
To determine the timing of acoustic hearing changes among hearing preservation Cochlear implant (CI) recipients. To determine differences in hearing outcomes based on device ...type and demographic factors. To determine if there is a relationship between the extent of early hearing loss after CI and the subsequent rate of continued hearing loss.
Study Design
Prospective, single subject study.
Methods
Two hundred and eleven subjects who received a hearing preservation CI were included in the study—80 Nucleus Hybrid L24 (Cochlear), 47 422/522 (Cochlear), 24 S8 (Cochlear), 14 S12 (Cochlear), 6 SRW (Cochlear), 21 SLIM J (Advanced Bionics), and 19 Flex (Med‐EL). Of these, 127 were included in the subsequent analyses. Audiometric thresholds (low frequency pure‐tone‐averages) were collected and compared pre and postoperatively.
Results
Long‐term hearing preservation rates were 65% (52/80) for L24, 83% (20/24) for S8, 79% (11/14) for S12, 83% (5/6) for SRW, 54% (25/47) for 422/522, 91% (21/23) for SLIM J, and 84% (16/19) for Flex. Hearing loss was not related to device type (P = .9105) or gender (P = .2169). Older subjects (age ≥65) had worse hearing outcomes than younger subjects after initial device activation (age <65, P = .0262). There was no significant difference in rate of hearing loss over time between older and younger patients (P = .0938). Initial postoperative hearing loss was not associated with the rate of long‐term hearing loss.
Conclusions
Long‐term low frequency hearing preservation is possible for CI recipients and is not associated with gender or device type. Rate of hearing loss over time is not dependent on patient age. Early hearing loss after CI does not predict the rate of long‐term hearing loss.
Level of Evidence
3 Laryngoscope, 132:2036–2043, 2022
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