To assess the safety of cochlear implants (CIs) in children under 9 months of age to better understand expected postoperative complication rates, and to provide a preliminary look at efficacy.
...Single-center retrospective review.
Tertiary referral center.
Children 5 to 8 months of age who received a CI between 2011 and 2021.
Therapeutic-CI.
The primary outcome was 6-month postoperative complication rate. Secondary outcomes included length of stay, device explantation/reimplantation, rehabilitation supports, and hearing and language outcomes. Complications of children implanted under than 9 months of age was compared with a cohort of children implanted 9 to 18 months of age between the years 2011 and 2016 using a chi-squared test ( p < 0.05).
One hundred six children under 9 months of age were implanted (204 CIs) at a mean age of 6.6 months (range: 5-8). Postoperative complications occurred in 28 patients (26%) and were often minor. There were no mortalities. There was no statistically significant difference in complications, including reimplantation rates, between patients implanted under 9 months of age and those implanted 9 to 18 months of age. Speech discrimination outcomes were excellent, and mean spoken language outcomes were near normative for typically developing children.
Cochlear implantation can be a safe and effective treatment option for children 5 to 8 months of age. Early hearing screening and referral for infants to receive appropriate intervention will continue to play a critical role in optimizing speech and language outcomes.
Five categories of cochlear implants are introduced: The 'classic CI', the 'combined CI' - which can be combining a CI based on electric stimulation with acoustic stimulation (EAS) or with mechanical ...stimulation (EMS) or with electrical stimulation of the vestibular system (VICI) -, the 'individualised CI', the 'augmented CI' and the 'totally implantable CI'. The translational research activities leading to and within these categories have been, are and will be numerous and are the subject of the compendium for which this paper is the concluding chapter. Early translational research has resulted in the 'classic CI' in 1994. From then on translational research enabled the developments respectively the new indications and reimbursement of CI-systems for bilateral CIs, CI in single sided deafness, the auditory brainstem implant, speech coding and signal processing advances, electrophysiologic measurements for evaluation of cochlear health, all within the classic CI category. Starting points for the four newer categories of CI are either ideas of professionals treating hearing loss or of CI developers. The translational research performed also triggered research that led and leads to improved understanding of the fundamental mechanisms of hearing.
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.
Here I identify two gaps in cochlear implants that have been limiting their performance and acceptance. First, cochlear implant performance has remained largely unchanged, despite the number of ...publications tripling per decade in the last 30 years. Little has been done so far to address a fundamental limitation in the electrode-to-neuron interface, with the electrode size being a thousand times larger than the neuron diameter while the number of electrodes being a thousand times less. Both the small number and the large size of electrodes produce broad spatial activation and poor frequency resolution that limit current cochlear implant performance. Second, a similarly rapid growth in cochlear implant volume has not produced an expected decrease in unit price in the same period. The high cost contributes to low market penetration rate, which is about 20% in developed countries and less than 1% in developing countries. I will discuss changes needed in both research strategy and business practice to close the gap between prosthetic and normal hearing as well as that between haves and have-nots.
Access to postoperative aural rehabilitation limits cochlear implant (CI) penetration to the candidate population. The purpose of this study was to evaluate the effectiveness of remote CI programming ...and aural rehabilitation via telehealth.
Retrospective study of one cochlear implant center.
Patients undergoing cochlear implantation from 2015 to 2018 undergoing remote programming as part of routine audiologic follow up.
AzBio scores, impedances, comfort and threshold levels, and responses to the International Outcome Inventory for Hearing Aids questionnaire modified for CIs (IOI-CI).
A total of 22 CIs in 20 patients were included during the study period. Threshold, comfort, and impedance levels were readily obtained via telehealth and were not significantly different between telehealth and live sessions. AzBio scores and warble tone pure tone averages were also similar and acceptable in both session modalities. Based on IOI-CI scores, patients were very satisfied with their hearing outcomes.
Using telemedicine, reliable measurements were readily obtained and hearing outcomes after remote programming were comparable to those expected after in-person programming sessions. Patients were overall satisfied with their remote programming sessions. Telehealth is a cost-effective and safe way to deliver post-CI audiologic care, particularly to patients with limited mobility or those in remote locations.
To evaluate the effectiveness of a 60/60 referral guideline for identifying patients who should be referred for a cochlear implant candidacy evaluation (CICE), which states patients should be ...referred if they demonstrate a best ear unaided monosyllabic word score less than or equal to 60% correct and if they demonstrate an unaided pure-tone average in their better ear that is greater than or equal to 60 dB HL.
Retrospective review of data from adults who participated in a CICE.
A single tertiary medical facility.
Five hundred twenty-nine patients who participated in a CICE.
CICEs included unaided threshold assessment, unaided speech recognition, and aided word and sentence testing.
Ninety-five percent of patients who met traditional indications for a cochlear implant (n = 250) had a pure-tone average that was greater than or equal to 60 dB, while 92% had a better ear unaided monosyllabic word score that was less than or equal to 60%.
If used as a screening measure, the 60/60 measure resulted in a 96% detection rate and a 34% false-positive rate for identifying adults who would meet traditional indications for a cochlear implant.
Hearing professionals should consider referring patients for a CICE when they meet the 60/60 guideline. It is hoped that provision of this guideline will result in greater numbers of adults being referred for CICEs, improving access to cochlear implants for patients who may benefit from this important technology.
This study aimed to longitudinally evaluate speech perception ability and sound-field thresholds with the first, second, or bilateral cochlear implants (CIs) and MAP parameters of second CI in ...children.
Eighteen children who underwent bilateral cochlear implantation at Kyoto University Hospital were included. We evaluated speech perception under quiet and noisy conditions using the first, second, or bilateral CIs, CI-aided sound-field thresholds using the first or second CI, and MAP parameter values (C-levels, T-levels, and dynamic range) of the second CI of more than 5 years after the second implantation.
Patients with a second CI after 7 years of age had significantly worse speech perception ability with the second CI even long after the surgery than those with a second CI before 7 years of age. CI-aided sound-field thresholds using the first or second CI were similar, regardless of the second implantation timing. Speech perception in noise with bilateral CIs was enhanced by the addition of a second CI, even after 7 years of age. Patients undergoing second cochlear implantation before 3.5 years of age showed significantly higher C-levels and wider dynamic ranges in the second CI MAP parameters.
When the second implantation was performed after 7 years of age, the second CI effects were limited even with long-term use, which is attributed to unstable MAP parameters. The second CI-aided sound-field threshold contributed to the better outcome of bilateral CIs in noise, even if the second implantation was performed at age of ≥7 years.
As cochlear implant (CI) candidacy has expanded, commercial payers in the United States have varied in their adoption of new indications, potentially confusing providers' knowledge about appropriate ...patients for referral. We reviewed how third-party payers classify the medical necessity of cochlear implants for a variety of indications across the lifespan.
We compared policies of the six largest commercial payers in our region, focusing on clinical scenarios for which many centers experience difficulty obtaining pre-authorization. These include: (1) CI in children under 12 months, (2) audiometric and speech perception criteria in children, (3) sequential bilateral CI, (4) electro-acoustic stimulation, (5) impending cochlear ossification, and (6) single-sided deafness (SSD).
Of the more notable findings for the clinical scenarios half of commercial payers have a pediatric age requirement of greater than 12 months. Generally, audiologic and speech perception criteria are more stringent for children than adults across all policies. SSD is considered investigational by most policies.
Third-party payers employ variable criteria regarding the medical necessity of CI, many of which are not contemporaneous with clinical knowledge and best practices. This may impact referral patterns among audiologists. More methodologically rigorous clinical trials may help shift such restrictive policies to benefit a greater number of patients.
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
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