Months Of Device Use Research Articles

Health-related quality of life in vibrant soundbridge patients: generic and specific measures, short-term and long-term outcomes

ObjectiveThe goal of the study was to determine the short- and long-term outcome of health-related quality of life (HRQoL) in adults implanted with a Vibrant Soundbridge (VSB).MethodsTwenty-one adults (8 females, 13 males; mean age at implantation: 57 ±10 years) who received a unilateral VSB for combined or conductive hearing loss, were administered two questionnaires: the Nijmegen Cochlear Implant Questionnaire (NCIQ) as a measure of hearing-specific HRQoL, and the Health Utility Index 3 (HUI 3) as a measure of generic HRQoL. The questionnaires were administered before implantation and three, six, 12 and 24 months after processor activation.ResultsThe NCIQ total score raised significantly from 62 points before implantation to 76 points at three months after processor activation (p < 0.005). Thereafter, no significant increases occurred anymore. The HUI 3 multi-attribute score (MAUS) increased from 0.59 before implantation to 0.70 at three months and at six months after processor activation and then declined slightly to 0.68 at 24 months after processor activation. Similar values were observed with the HUI 3 single-attribute score (SAUS) of Hearing. The increases of the HUI 3 scores were not statistically significant, but all pre-post-implantation differences were clinically relevant.DiscussionVSB recipients experienced a quick improvement of their HRQoL. After just three months of device use, a significant improvement of hearing-specific HRQoL and a clinically relevant improvement of generic HRQoL were seen. After three months, no essential changes of HRQoL occurred in our sample, suggesting that the achieved level of HRQoL may remain stable in the long term.

QoL, CIs, QALYs, and Individualized Rehabilitation: The Clinical and Practical Benefits of Regularly Assessing the Quality of Life of Adult Cochlear Implant Recipients.

This study aimed to report quality of life (QoL) scores in unilateral cochlear implant (CI) users and to generate guidance for clinicians on using QoL measures to individualize CI counselling and rehabilitation and to increase access to CIs as a mode of rehabilitation. Participants (n = 101) were unilateral CI users with single-sided deafness (SSD; n = 17), asymmetrical hearing loss (AHL; n = 26), or bilateral hearing loss (Uni; n = 58). Generic QoL was assessed via the Health Utilities Index (HUI-3), and disease-specific QoL was assessed via the Speech, Spatial, and Qualities of Hearing scale (SSQ12) and Nijmegen CI Questionnaire (NCIQ) at preimplantation and at 6 and 12 months of CI use. All groups had significantly increased HUI-3 scores at both intervals. The SSD group showed significant benefit on the SSQ12 at visit 3, the AHL group showed significant benefit on the SSQ12 and most NCIQ subdomains at both intervals, and the Uni group showed significant benefit with both tests at both intervals. Unilateral CI recipients demonstrate improved QoL within the first 12 months of device use. Regular assessment with generic and disease-specific questionnaires has the potential to play an important role in personalizing treatment and possibly in increasing access to CI provision.

Dynamic Range and Neural Response Threshold in Cochlear Implant Mapping Can Be Useful in Predicting Prognosis Related to Postoperative Speech Perception.

To analyze mapping changes in dynamic range (DR) and neural response threshold (NRT) as prognostic factors for cochlear implant (CI). To analyze whether postoperative speech perception performance could be predicted using DR change and initial NRT. The speech comprehension data of 33 patients with CI were retrospectively analyzed after 1, 3, 6, and 12 months of device use. All subjects were adult, postlingually hearing-impaired, and Cochlear Nucleus CI users. Speech perception performance was evaluated using aided pure tone audiometry, consonant, vowel, one-word, two-word, and sentence tests. The averages of initial NRT and DR changes were 197.8±25.9 CU (104-236) and 22.2±18.4 CU (-15-79), respectively. The initial DR was 40.8±16.6 CU. The postoperative DR was 50.3±16.4 CU at 3 months, 58±12.3 CU at 6 months, and 62.9±10.4 CU at 12 months. A gradual increase of DR was observed during the first year of CI. Compared with the initial DR, significant increases in DR were observed at 3 (p<0.05), 6 (p<0.001), and 12 (p<0.001) months. Compared with initial speech performance outcomes, a significant gain in all performance outcomes was achieved at 12 months (p<0.001). Patients with low NRT after CI surgery could initially set DR to a wider range and had better final speech perception outcomes. Conversely, patients with high NRT after CI surgery had to set up a gradual increase in DR while adjusting the T-C level, and the final speech perception outcomes were worse. DR and NRT, the main CI mapping variables, can help predict prognosis related to speech perception outcomes after CI surgery. In conclusion, the post-CI speech perception is better with a lower initial NRT, wider final DR, or younger age.

3D printing for respiratory physiotherapy: a tale of three disciplines

A 78-year-old patient with a laryngectomy and a background of bronchiectasis experienced frequent hospital admissions due to pulmonary exacerbations. Standard care would be to trial a positive expiratory pressure (PEP) device to assist with secretion removal, however, no adaptor could be found to contour the patient's tracheostoma. A 3D printed patient-specific PEP adaptor was created, facilitating regular secretion clearance via PEP therapy. Frequency of hospital admissions and outcomes of disease-specific questionnaires (St. George's Respiratory Questionnaire (SGRQ) and Leicester Cough Questionnaire (LCQ)) were evaluated at three and six months. After six months of device use, the patient had not experienced a pulmonary exacerbation or required an admission, whilst demonstrating clinically significant improvements in both SGRQ (58.98 vs. 66.3/100) and LCQ (11.27 vs. 13.27/21) scores. Collaboration between consumers, clinicians and engineers can support the delivery of personalised healthcare and improve quality of life for patients with pulmonary conditions.

The Feasibility of Home-Based Treatment Using Vibratory Stimulation in Chronic Severe Dysphagia.

Previously, externally placed vibratory laryngeal stimulation increased rates of swallowing in persons with and without dysphagia. This study examined the feasibility of using a vibratory device on the skin over the thyroid cartilage for home-based swallowing rehabilitation in long-standing dysphagia. Only participants with long-standing dysphagia (> 6 months) following cerebrovascular accident or head/neck cancer who had not previously benefited from dysphagia therapy participated. The device had two modes used daily for 90 days. In automatic mode, participants wore the device when awake, which vibrated for 4-8 s every 5 min to trigger a volitional swallow. In manual mode, participants practiced by activating vibration while swallowing rapidly. Study-related adverse events, such as pneumonia, and device-recorded adherence were tracked. Swallowing function on a modified barium swallow study was assessed at baseline and after 3 months of device use. Outcome measures included the Dysphagia Outcome and Severity Scale (DOSS), Penetration-Aspiration Scale (PAS), and swallowing timing measures. Participants' perceptions of the vibratory device and training were obtained. The intent to treat analysis showed seven of 11 participants completed the study, all with severe chronic dysphagia. Of those seven participants completing the study, two developed respiratory complications (possibly due to pneumonia) that cleared after antibiotic intervention. For prescribed practice trials, adherence was 80% or greater in four of seven participants (57%) whereas prescribed automatic stimulations were met in only two of seven participants (29%). Three participants (43%) had a modest benefit on DOSS. The time to vestibule closure after the bolus passed the ramus was reduced in five participants (71%) on the modified barium swallow study. Overall, the results have indicated that intensive home-based practice with stimulation may provide limited functional benefits in severe chronic dysphagia. https://doi.org/10.23641/asha.21498591.

ACTIVE DECOMPRESSION AND DISTRACTION SUGOSTEOGENESIS AS A NOVEL TREATMENT FOR ODONTOGENIC KERATOCYST: A CASE REPORT

The Odontogenic Keratocyst is a rare but benign developmental cyst of the oral cavity that arises from cell rests of dental lamina; it is aggressive and typically appears during the second and third decades of life. It is usually detected incidentally or by asymptomatic swelling; 50% of them are commonly located in the posterior body and lower ramus of the mandible. <b>Objective:</b> present the effectiveness of a novel treatment for cyst decompression and distraction sugosteogenesis.<b>Clinical presentation:</b> A 59-year-old female was referred to clinic due to painless swelling in her posterior left side of the oral cavity with one year of evolution. The mass measured 2cmx2cm. After biopsy, a diagnosis of Odontogenic Keratocyst was determined. Radiographical evaluation showed a mass that started at the middle of the ramus and extended to the roots of the second molar, cortical bone from inferior border of the mandible was compromised.<b>Intervention and Outcome:</b> Active decompression of the cyst was elected as the treatment path. The application of negative pressure to osseous cells produces a stretching that creates mechanical cues that trigger signaling pathways, promote fluid flow, and enhance angiogenesis.²Two bone windows were performed on the buccal aspect of the cyst, and a tube was placed into each one of them. One tube was connected to a saline bag, and the other tube was connected to a Hemovac device. For one month, the patient manually irrigated with saline the inside of the cyst through one of the tubes, and manually used the Hemovac pump to aspirate the water out of the cavity. This procedure was performed three times daily.<b>Results:</b> After three months, radiographic evaluation showed remarkable cyst decompression.<b>Conclusions:</b> After three months of device use, we believe it has the potential to remarkably reduce the size of cystic lesions through distraction sugosteogenesis.

Using Generic and Disease-Specific Measures to Assess Quality of Life before and after 12 Months of Hearing Implant Use: A Prospective, Longitudinal, Multicenter, Observational Clinical Study.

The primary objectives of this study were to evaluate the effect of hearing implant (HI) use on quality of life (QoL) and to determine which QoL measure(s) quantify QoL with greater sensitivity in users of different types of HIs. Participants were adult cochlear implant (CI), active middle ear implant (VIBRANT SOUNDBRIDGE (VSB)), or active transcutaneous bone conduction implant (the BONEBRIDGE (BB)) recipients. Generic QoL and disease-specific QoL were assessed at three intervals: pre-activation, 6 months of device use, and 12 months of device use. 169 participants completed the study (110 CI, 18VSB, and 41BB). CI users’ QoL significantly increased from 0–6 m device use on both the generic- and the disease-specific measures. On some device-specific measures, their QoL also significantly increased between 6 and 12 m device use. VSB users’ QoL significantly increased between all tested intervals with the disease-specific measure but not the generic measure. BB users’ QoL significantly increased from 0–6 m device use on both the generic- and the disease-specific measures. In sum, HI users experienced significant postoperative increases in QoL within their first 12 m of device use, especially when disease-specific measures were used. Disease-specific QoL measures appeared to be more sensitive than their generic counterparts.

Preoperative Imaging of Temporoparietal Scalp Thickness Predicts Off-the-Ear Sound Processor Retention in Cochlear Implants With Diametric Magnets.

To determine if temporoparietal scalp thickness assessed via preoperative imaging predicts retention events in patients who have cochlear implants with diametric magnets and various sound processor types. Retrospective chart and radiological review. Tertiary referral center. One hundred forty-three adult patients who have cochlear implants with diametric magnets. Skin flap thickness, retention events, body mass index (BMI), and magnet strength. Of 42 patients with the most recent generation off-the-ear sound processor (OTE2), 13 (31.0%) had retention events. Of patients with a temporoparietal scalp thickness less than 8 mm, all patients could ultimately retain the device, though one of 26 was noted to have tenuous retention. Of patients with 8 to 10 mm skin flaps, 3 of 6 (50%) could not retain the device, and with more than 10 mm skin flaps, 7 of 10 (70%) could not retain the device. In the more than 10 mm group, two additional patients could not either retain the device at initial activation or were noted to have tenuous retention. Of 124 patients with behind-the-ear (BTE) sound processors, only 2 (1.6%) could not retain the device at initial activation, and 3 (2.4%) exhibited tenuous retention after 3 months of device use. Results from the first generation off-the-ear sound processor (OTE1) are also reported. Temporoparietal scalp thickness measured by preoperative imaging is associated with processor retention for patients with the OTE2 sound processor and diametric magnets. All patients with less than 8 mm scalp thickness could retain the OTE2, while 50% of patients with 8 to 10 mm scalp thickness and 70% with more than 10 mm scalp thickness could not retain the device. Patients should be counseled regarding their sound processor choice and/or considered candidates for skin flap reduction or other intervention as indicated. Retention events with BTE processors are rare.

Central auditory maturation and behavioral outcomes after cochlear implantation in prelingual auditory neuropathy spectrum disorder related to OTOF variants (DFNB9): Lessons from pilot study.

The cortical auditory evoked potential (CAEP)-based P1 component acts as a biomarker for cochlear implantation (CI) outcomes in children with auditory neuropathy spectrum disorder (ANSD). To date, early intervention primarily before the age of two years and six months of CI usage is necessary and sufficient to achieve age-appropriate cortical maturation and good prognosis. However, varying degrees of neural dyssynchrony, resulting from the etiological heterogeneity of ANSD, may preclude uniform application of this hypothesis to ensure auditory cortical maturation. Thus, a focused evaluation of those carrying OTOF variants, which may be the salient molecular etiology of prelingual ANSD, would circumvent the issue of heterogeneity. Here, we sought to provide a much better understanding of the brain perspectives (i.e., P1 maturation) in OTOF-associated ANSD subjects and set the stage for an optimal strategy to enhance language development. We conducted a preliminary study comprising 10 subjects diagnosed with OTOF-related ANSD who underwent CI by a single surgeon and subsequently underwent measurements of the P1 component. We observed that DFNB9 subjects who received CI after 2 years of age exhibited “absent” or “anomalous” P1 components that correspond to delayed language development. However, timely implantation, as early as 12 months of age per se, might be insufficient to achieve age-appropriate cortical maturation of DFNB9 in cases with six to seven months of device use. This suggests the importance of sustained rehabilitation in DFNB9 than in other etiologies. Indeed, an additional follow-up study showed that a reduction in P1 latency was linked to an improvement in auditory performance. Collectively, our results suggest that central auditory maturation and successful outcome of CI in DFNB9 may have more demanding requirements, that is, earlier implantation and more sustained rehabilitation. We believe that the current study opens a new path toward genome-based neuroimaging in the field of hearing research.

Clinical implications of intraoperative eABRs to the Evo®-CI electrode array recipients

IntroductionElectrically evoked auditory brainstem responses provide reliable clinical information to assist professionals in the auditory rehabilitation of cochlear implant users. ObjectiveThis study aimed to investigate intraoperative evoked auditory brainstem response recordings in Evo®-cochlear implant electrode array recipients and its correlation with their behavioral levels and auditory performance. Methods: This is a retrospectivey study. Intraoperative evoked auditory brainstem responses were recorded in adult Evo®-cochlear implant electrode array recipients. Wave V latencies, amplitudes and interpeak III–V intervals were recorded in three different electrode locations and compared to the sentence recognition scores obtained from subjects after six months of device use. Evoked auditory brainstem responses thresholds were also recorded and compared to the behaviorally determined levels of the subjects in the sound processor activation. ResultsEvoked auditory brainstem responses thresholds were significantly correlated with both, behavioral T- and C-levels and they were recorded at audible electrical stimulation levels in all subjects. There was a significant correlation between interpeak III–V interval recorded in the apical electrode and sentence recognition scores of the subjects. ConclusionsIntraoperative evoked auditory brainstem responses can be used to establish audible levels for fitting the sound processor in Evo®-cochlear implant recipients and it could help professionals to plan further actions aiming to improve their auditory performance.

Do the minimum and maximum comfortable stimulation levels influence the cortical potential latencies or the speech recognition in adult cochlear implant users?

IntroductionCochlear implants (CI) programming is based on both the measurement of the minimum levels required to stimulate the auditory nerve and the maximum levels to generate loud, yet comfortable loudness. Seeking for guidance in the adequacy of this programming, the cortical auditory evoked potentials (CAEP) have been gaining space as an important tool in the evaluation of CI users, providing information on the central auditory system. ObjectiveTo evaluate the influence of mishandling of electrical stimulation levels on speech processor programming on hearing thresholds, speech recognition and cortical auditory evoked potential in adult CI users. Material and methodsThis is a prospective cross-sectional study, with a sample of adult unilateral CI users of both sexes, aged at least 18 years, post-lingual deafness, with minimum experience of 12 months of device use. Selected subjects should have average free field hearing thresholds with cochlear implant equal to or better than 34 dBHL and monosyllable recognition different from 0%. Individuals who could not collaborate with the procedures or who had no CAEP recordings were excluded. Participants were routinely programmed, and the map was named MO (optimized original map). Then three experimentally wrong maps were made: optimized original map with 10 current units below the maximum comfort level (C), named MC- (map minus C); optimized original map with minus 10 current units at minimum threshold level (T), named MT- (map minus T) and optimized original map with 10 current units above minimum level (T), named MT + (map plus T). In all programs, participants underwent free-field auditory thresholds from 250Hz to 6000Hz, recorded sentences and monosyllabic recognition tests presented at 65dB SPL in quiet and in noise, and free field CAEP evaluation. All tests were performed in an acoustically treated booth, in a randomized order of map presentation. Data were compared by Wilcoxon test. ResultsThirty individuals were selected and signed an informed consent form. The MC- map provided worsening of all free field thresholds, quiet and noise speech recognition, and P1 wave latency delay with significant difference from the results with the MO map. The MT- map worsened the hearing thresholds and statistically significantly reduced the P2 wave latency; MT+ map improved free field thresholds except 6000Hz, worsening speech recognition, without statistical significance. ConclusionsThe results suggest that maximum levels below the optimal thresholds lead to worse cochlear implant performance in both hearing thresholds and speech recognition tests in quiet and noise, increasing CAEP component P1 latency. On the other hand, the manipulation of minimum threshold levels showed alteration in audibility without significant impact on speech recognition.

Longitudinal outcomes of cochlear implantation and bimodal hearing in a large group of adults: A multicenter clinical study.

To evaluate speech understanding outcomes in a large adult cohort who demonstrated poor hearing performance with well fit hearing aids in the unilateral and bilateral or bimodal listening conditions at preimplant, 3-, 6- and 12-months. Post-linguistically deafened adults (N=100) with bilateral moderate-to-profound sensorineural hearing loss and limited functional benefit from well fit bilateral hearing aids. A multicenter, prospective, repeated-measures, within-subject controlled study was conducted. All subjects were implanted with a Slim Modiolar cochlear implant and were required to use bimodal stimulation (cochlear implant and hearing aid in contralateral ear) for 6-months postimplant and optionally to 12-months. Evaluations included: speech recognition for monosyllabic consonant-nucleus-consonant (CNC) words in quiet; AzBio sentences in coincident noise (at +5 and +10dB signal-to-noise ratio (SNR)), in implant ear and bimodal conditions. All speech tests were performed at preimplant and 6-months postimplant for primary endpoint outcomes, and a subset of speech tests at 3- and 12-months. In the implant ear only, at 3-, 6- and 12-months postimplant, 84%, 93% and 97% of subjects respectively, demonstrated significantly improved monosyllabic word scores in quiet compared to preimplant hearing aid scores (p<0.05). At 12-months, a mean gain of 51% points, for monosyllabic words and 32% points for sentences in noise was observed (p<0.001). In the bimodal condition, at 6-months postimplant, 87% of subjects demonstrated significantly improved monosyllabic word scores in quiet compared to preimplant bilateral hearing aid scores (p<0.05). At 6-months, a mean gain of 40% points, for monosyllabic words was observed (p<0.001). Speech scores for sentences in noise significantly improved for the bimodal condition at 6- and 12-months (p<0.001). In addition to speech scores for the implanted ear, bimodal condition scores demonstrated further increments, especially for sentences in noise at 6- and 12-months (p<0.001). Results support that bimodal hearing is superior to bilateral hearing aids in this cohort of bilateral moderate-to-profound adult hearing aid users. Our study cohort demonstrated significant improvements for speech scores for the cochlear implant (CI) ear only and bimodal conditions compared to the baseline preimplant unilateral and bilateral hearing aid conditions respectively. The greatest gain in performance was in the first three months of device use with incremental improvement through 12months. These findings indicate that when hearing aids fit to National Acoustics Laboratory (NAL-1) targets do not provide the necessary audibility needed for speech recognition, referral for CI-candidacy evaluation is strongly recommended. Clintrial.govNCT03007472. Registered 01/02/2017, https://clinicaltrials.gov/ct2/show/NCT03007472?term=clinical+evaluation+of+the+nucleus+CI532&draw=2&rank=2.

Frequency-to-Place Mismatch: Characterizing Variability and the Influence on Speech Perception Outcomes in Cochlear Implant Recipients.

The spatial position of a cochlear implant (CI) electrode array affects the spectral cues provided to the recipient. Differences in cochlear size and array length lead to substantial variability in angular insertion depth (AID) across and within array types. For CI-alone users, the variability in AID results in varying degrees of frequency-to-place mismatch between the default electric frequency filters and cochlear place of stimulation. For electric-acoustic stimulation (EAS) users, default electric frequency filters also vary as a function of residual acoustic hearing in the implanted ear. The present study aimed to (1) investigate variability in AID associated with lateral wall arrays, (2) determine the subsequent frequency-to-place mismatch for CI-alone and EAS users mapped with default frequency filters, and (3) examine the relationship between early speech perception for CI-alone users and two aspects of electrode position: frequency-to-place mismatch and angular separation between neighboring contacts, a metric associated with spectral selectivity at the periphery. One hundred one adult CI recipients (111 ears) with MED-EL Flex24 (24 mm), Flex28 (28 mm), and FlexSOFT/Standard (31.5 mm) arrays underwent postoperative computed tomography to determine AID. A subsequent comparison was made between AID, predicted spiral ganglion place frequencies, and the default frequency filters for CI-alone (n = 84) and EAS users (n = 27). For CI-alone users with complete insertions who listened with maps fit with the default frequency filters (n = 48), frequency-to-place mismatch was quantified at 1500 Hz and angular separation between neighboring contacts was determined for electrodes in the 1 to 2 kHz region. Multiple linear regression was used to examine how frequency-to-place mismatch and angular separation of contacts influence consonant-nucleus-consonant (CNC) scores through 6 months postactivation. For CI recipients with complete insertions (n = 106, 95.5%), the AID (mean ± standard deviation) of the most apical contact was 428° ± 34.3° for Flex24 (n = 11), 558° ± 65.4° for Flex28 (n = 48), and 636° ± 42.9° for FlexSOFT/Standard (n = 47) arrays. For CI-alone users, default frequency filters aligned closely with the spiral ganglion map for deeply inserted lateral wall arrays. For EAS users, default frequency filters produced a range of mismatches; absolute deviations of ≤ 6 semitones occurred in only 37% of cases. Participants with shallow insertions and minimal or no residual hearing experienced the greatest mismatch. For CI-alone users, both smaller frequency-to-place mismatch and greater angular separation between contacts were associated with better CNC scores during the initial 6 months of device use. There is significant variability in frequency-to-place mismatch among CI-alone and EAS users with default frequency filters, even between individuals implanted with the same array. When using default frequency filters, mismatch can be minimized with longer lateral wall arrays and insertion depths that meet the edge frequency associated with residual hearing for CI-alone and EAS users, respectively. Smaller degrees of frequency-to-place mismatch and decreased peripheral masking due to more widely spaced contacts may independently support better speech perception with longer lateral wall arrays in CI-alone users.

Efficacy, Safety, and Tolerability of a New Low-Dose Copper and Nitinol Intrauterine Device

To assess in parous and nulliparous women, the efficacy, safety, and tolerability of a new, low-dose copper (175 mm) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator. Institutional review boards at 12 U.S. sites approved this commercially funded project. Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Intrauterine device placement occurred at any day in the eligible patient's menstrual cycle after assuring she was not pregnant. The primary outcome measure assessed efficacy (measured by the Pearl Index) in this 1-year study with a 2-year extension. Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns. A total of 286 women provided 5,640 cycles evaluable for pregnancy. Patients averaged 27.1 years of age. Nulliparous women represented 60.8% of the patients. Over 36 months of observation, we identified two pregnancies (Pearl Index 0.46 [95% CI 0.06-1.67]) and 10 serious adverse events; none were study-related. Successful placement occurred in 283 participants (99.0%). Median (range) continuation times were 2.7 years (0-3.4). We identified five expulsions (1.8%), zero uterine perforations, and one report of pelvic inflammatory disease. Adverse events prompted 30 women (10.6%) to discontinue early in the first year of use with 23 (8.1%) discontinuing for issues of bleeding, pain, or both. Altogether, 107 (37.8%) completed 36 months of device use. Mean bleeding days per cycle decreased from 7.6 in cycle 1 to 5.2 in cycle 13. The novel, low-dose copper and nitinol IUD demonstrated high efficacy and safety in this phase 2 U.S. Food and Drug Administration trial and warrants further expanded study in a phase 3 clinical trial. ClinicalTrials.gov, NCT02446821. Sebela Pharmaceuticals, Inc.

Motor neuroprosthesis for promoting recovery of function after stroke.

Motor neuroprosthesis for promoting recovery of function after stroke.

Electric-Acoustic Stimulation Outcomes in Children.

This study investigates outcomes in children fit with electric-acoustic stimulation (EAS) and addresses three main questions: (1) Are outcomes with EAS superior to outcomes with conventional electric-only stimulation in children? (2) Do children with residual hearing benefit from EAS and conventional electric-only stimulation when compared with the preoperative hearing aid (HA) condition? (3) Can children with residual hearing derive benefit from EAS after several years of listening with conventional electric-only stimulation? Sixteen pediatric cochlear implant (CI) recipients between 4 and 16 years of age with an unaided low-frequency pure tone average of 75 dB HL in the implanted ear were included in two study arms. Arm 1 included new recipients, and Arm 2 included children with at least 1 year of CI experience. Using a within-subject design, participants were evaluated unilaterally with the Consonant-Nucleus-Consonant (CNC) word list in quiet and the Baby Bio at a +5 dB SNR using an EAS program and a conventional full electric (FE) program. Arm 1 participants' scores were also compared with preoperative scores. Speech perception outcomes were statistically higher with the EAS program than the FE program. For new recipients, scores were significantly higher with EAS than preoperative HA scores for both the CNC and Baby Bio in noise; however, after 6 months of device use, results in the FE condition were not significantly better than preoperative scores. Long-term FE users benefited from EAS over their FE programs based on CNC word scores. Whether newly implanted or long-term CI users, children with residual hearing after CI surgery can benefit from EAS. Cochlear implantation with EAS fitting is a viable option for children with HAs who have residual hearing but have insufficient access to high-frequency sounds and poor speech perception.

Controlled comparative clinical trial of hearing benefit outcomes for users of the Cochlear™ Nucleus® 7 Sound Processor with mobile connectivity

Objectives: To assess subjective benefits and objective speech recognition performance following a take-home trial with the new Cochlear™ Nucleus® 7 Sound Processor (SP), in experienced users of compatible cochlear implants from Cochlear Limited.Methods: A total of 37 adult participants were fitted with the Nucleus 7 SP and used the device for up to one year. Baseline speech recognition was assessed at the initial fitting session, using each participant’s own SP, and Client Oriented Scale of Improvement (COSI) goals were identified. Speech recognition was measured after 3 months of device use and outcomes of the COSI and a non-validated Processor Comparison Questionnaire (PCQ) were collected. After 11 months, a subset of subjects were tested on speech recognition delivered via direct wireless streaming from an Apple® smartphone to the SP and compatible hearing aid on the opposite side (if worn).Results: The COSI and PCQ instruments both indicated significant improvement in perceived subjective benefits in comparison to the participants’ previous SPs. Direct streaming via an Apple mobile phone showed improvements when compared with the acoustic alone condition. Standard speech recognition in quiet and noise was equivalent to that obtained using a previous generation SP which uses the same basic processing as the Nucleus 7 Sound Processor.Conclusions: The incremental refinements provided by the Nucleus 7 Sound Processor provide real-world benefits in key areas such as upgraded wireless connectivity. The COSI proved to be an effective tool for individualized assessment of specific benefits that may not be addressed by more standardized instruments.

Tongue motion variability with changes of upper airway stimulation electrode configuration and effects on treatment outcomes.

Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA). Previous data have demonstrated a correlation between the phenotype of tongue motion and therapy response. Closed loop hypoglossal nerve stimulation implant offers five different electrode configuration settings which may result in different tongue motion. Two-center, prospective consecutive trial in a university hospital setting. Clinical outcomes of 35 patients were analyzed after at least 12 months of device use. Tongue motion was assessed at various electrode configuration settings. Correlation between the tongue motion and treatment response was evaluated. OSA severity was significantly reduced with the use of UAS therapy (P < .001). Changes in tongue motion patterns were frequently observed (58.8%) with different electrode configuration settings. Most of the patients alternated between right and bilateral protrusion (73.5%), which are considered to be the optimal phenotypes for selective UAS responses. Different voltage settings were required to achieve functional stimulation levels when changing between the electrode settings. UAS is highly effective for OSA treatment in selected patients with an apnea-hypopnea index between 15 and 65 events per hour and higher body mass index. Attention should be given to patients with shifting tongue movement in response to change of electrode configuration. The intraoperative cuff placement should be reassessed when tongue movement shifting is observed. 4 Laryngoscope, 1970-1976, 2018.

Level of emotion comprehension in children with mid to long term cochlear implant use: How basic and more complex emotion recognition relates to language and age at implantation

ObjectivesThe current study was designed with three main aims: To document the level of emotional comprehension skills, from basic to more complex ones, reached by a wide sample of cochlear implant (CI) deaf children with at least 36 months of device use; To investigate subjective and audiological factors that can affect their emotional development; To identify, if present, a “critical age”, in which early intervention might positively affect adequate emotional competence development. DesignThis is an observational cohort study. Children with congenital severe/profound deafness were selected based on: aged by 4–11 years, minimum of 36 months of CI use, Italian as the primary language in the family; normal cognitive level and absence of associated disorders or socio-economic difficulties. Audiological characteristics and language development were assessed throughout standardized tests, to measure speech perception in quiet, lexical comprehension and production. The development of emotions' understanding was assessed using the Test of Emotion Comprehension (TEC) of Pons and Harris, a hierarchical developmental model, where emotion comprehension is organized in 3 Stages (external, mental and reflective). Statistical analysis was accomplished via the Spearman Rank Correlation Coefficient, to study the relationship between the personal and audiological characteristics; a multivariate linear regression analysis was carried out to find which variables were better associated with the standardized TEC values; a chi-squared test with Yate's continuity correction and Mann-Whitney U test were used to account for differences between continuous variables and proportions. Results72 children (40 females, 32 males) with a mean age of 8.1 years were included. At TEC score, 57 children showed normal range performances (79.17% of recipients) and 15 fell below average (20.83% of recipients). The 16.63% of older subjects (range of age 8–12 years) didn't master the Stage 3 (reflective), which is normally acquired by 8 years of age and failed 2 or all the 3 items of this component. Subjects implanted within 18 months of age had better emotion comprehension skills. TEC results were also positively correlated with an early diagnosis, a longer implant use, better auditory skills and higher scores on lexical and morphosintactic tests. On the contrary, it was negatively correlated with the presence of siblings and the order of birth. The gender, the side and the severity of deafness, type of implant and strategy were not correlated. ConclusionsEarly implanted children have more chance to develop adequate emotion comprehension, especially when the complex aspects are included, due to the very strong link between listening and language skills and emotional development. Furthermore, longer CI auditory experience along with early intervention allows an adequate communication development which positively influences the acquisition of such competencies.

Speech perception in adolescents with pre-lingual hearing impairment with cochlear implants

Profound hearing loss is a disability that affects personality and when it involves teenagers before language acquisition, these bio-psychosocial conflicts can be exacerbated, requiring careful evaluation and choice of them for cochlear implant. AimTo evaluate speech perception by adolescents with profound hearing loss, users of cochlear Implants. Study DesignProspective. Materials and MethodsTwenty-five individuals with severe or profound pre-lingual hearing loss who underwent cochlear implantation during adolescence, between 10 to 17 years and 11 months, who went through speech perception tests before the implant and 2 years after device activation. For comparison and analysis we used the results from tests of four choice, recognition of vowels and recognition of sentences in a closed setting and the open environment. ResultsThe average percentage of correct answers in the four choice test before the implant was 46.9% and after 24 months of device use, this value went up to 86.1% in the vowels recognition test, the average difference was 45.13% to 83.13% and the sentences recognition test together in closed and open settings was 19.3% to 60.6% and 1.08% to 20.47% respectively. ConclusionAll patients, although with mixed results, achieved statistical improvement in all speech tests that were employed.