Long-term voice outcomes of medialization thyroplasty with adjustable implant for unilateral vocal fold paralysis.

OBJECTIVES: Medialization thyroplasty (MT) using various implants has been employed as a corrective procedure for unilateral vocal fold paralysis (UVFP). A newly developed APrevent® vocal implant system (VOIS) offers an innovative solution with a finely adjustable design. This study aimed to investigate the long-term functional voice outcomes and benefits of postoperative adjustments in patients receiving MT using the VOIS-implant. METHODS: This is a prospective case series study at single tertiary medical center. Fourteen adult patients diagnosed with UVFP received MT with the VOIS implant and were followed up for more than 1 year. Implant adjustment procedure by injecting 0.9% physiological saline solution was performed both during and after the surgery to optimize glottal closure and voice quality. Objective voice outcomes and acoustic parameters were assessed preoperatively and postoperatively at various timepoints. RESULTS: Thirteen patients (93%) received intraoperative balloon adjustment, ranging from 0.05to 0.12 ml. Four patients underwent adjustments postoperatively and exhibited a positive trend towards immediately improving acoustic voice quality. Our long-term results demonstrated a notable improvement after the surgery in voice quality, with significant decreases in VHI-30 and improvements in perceptual parameters of GRBAS scale, acoustic measures such as jitter and signal-to-noise ratio (p < 0.001) and cepstral peak prominence smoothed in sustained vowel and short sentences. The voice outcomes remained stable more than 1 year follow-up. CONCLUSIONS: Overall, MT with VOIS implantation provides a favorable long-term outcomes and stability in voice quality for patients with UVFP and also an effective tool for postoperative adjustment without major revision surgeries.

Enhancing the Performance of Pathological Voice Quality Assessment System Through the Attention-Mechanism Based Neural Network.

OBJECTIVE: Doctors, nowadays, primarily use auditory-perceptual evaluation, such as the grade, roughness, breathiness, asthenia, and strain scale, to evaluate voice quality and determine the treatment. However, the results predicted by individual physicians often differ, because of subjective perceptions, and diagnosis time interval, if the patient's symptoms are hard to judge. Therefore, an accurate computerized pathological voice quality assessment system will improve the quality of assessment. METHOD: This study proposes a self_attention-based system, with a deep learning technology, named self_attention-based bidirectional long-short term memory (SA BiLSTM). Different pitches [low, normal, high], and vowels [/a/, /i/, /u/], were added into the proposed model, to make it learn how professional doctors evaluate the grade, roughness, breathiness, asthenia, and strain scale, in a high dimension view. RESULTS: The experimental results showed that the proposed system provided higher performance than the baseline system. More specifically, the macro average of the F1 score, presented as decimal, was used to compare the accuracy of classification. The (G, R, and B) of the proposed system were (0.768±0.011, 0.820±0.009, and 0.815±0.009), which is higher than the baseline systems: deep neural network (0.395±0.010, 0.312±0.019, 0.321±0.014) and convolution neural network (0.421±0.052, 0.306±0.043, 0.3250±0.032) respectively. CONCLUSIONS: The proposed system, with SA BiLSTM, pitches, and vowels, provides a more accurate way to evaluate the voice. This will be helpful for clinical voice evaluations and will improve patients' benefits from voice therapy.

Pre-clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization.

Objective: To evaluate the concept and efficacy of an adjustable implant (Prototype SH30: porcine implant and APrevent® VOIS: human concept) for treatment of unilateral vocal fold paralysis (UVFP) via in vivo mini-pig studies, human computed tomographic (CT) and magnetic resonance (MR) image analysis, ex-vivo aerodynamic and acoustic analysis. Methods: Feasibility testing and prototype implantation were performed using in-vivo UVFP porcine model (n = 8), followed by a dimensional finding study using CT and MR scans of larynges (n = 75) for modification of the implant prototypes. Acoustic and aerodynamic measurements were recorded on excised canine (n = 7) larynges with simulated UVFP before and after medialization with VOIS-Implant. Results: The prototype showed in the in-vivo UVFP porcine model an improved glottic closure from grade 6 incomplete closure to complete closure (n = 5), to grade 2 incomplete closure (n = 2) and grade 3 incomplete closure (n = 1). On human CT/MR scans the identification of the correct size was successful in 97.3% using the thyroid cartilage alar "distance S" as the only parameter, which is an important step towards procedure standardization and implant design. Results were confirmed with implantation in human laryngeal cadavers (n = 44). Measurements of the acoustic and aerodynamic effects after implantation showed a significant decreased phonation threshold pressure (p = .0187), phonation threshold flow (p = .0001) and phonation threshold power (p = .0046) on excised canine larynges with simulated UVFP. Percent jitter and percent shimmer decreased (p = .2976; p = .1771) but not significant. Conclusions: Based on the preclinical results four sizes, differing in medial length, implant width and expansion direction of silicone cushions, seem to be enough to satisfy laryngeal size variations. This concept is significantly effective in medializing UVFP and improving the aerodynamic and acoustic qualities of phonation as reported in a preliminary clinical outcome study with long-term implantation. Level of Evidence: N/A.

Preliminary Clinical Outcomes of VOIS-Implant in Patients With Unilateral Vocal Fold Paralysis.

OBJECTIVES/HYPOTHESIS: Evaluation of the clinical outcomes after 6 months of treatment with a novel adjustable implant, the APrevent® Vocal-Implant-System (VOIS), in conjunction with medialization thyroplasty (MT) in patients with unilateral vocal fold paralysis. STUDY DESIGN: Prospective case series study at single tertiary referral center. METHODS: Preoperative and 1 week, 7 weeks, and 6 months postoperative glottal efficiency (maximum phonation time [MPT]), voice quality (including GRBAS-scores and acoustic parameters) and self-perceived voice-related handicap (voice handicap index [VHI-30]) were measured and analyzed, whereas type of vocal fold closure was evaluated and determined by flexible videolaryngoscopy based on Södersten and Lindestad classification (Wilcoxon signed-rank test). RESULTS: Thirteen patients underwent MT with VOIS under local anesthesia. Six months after surgery, the VHI-30 and MPT had improved from a preoperative mean of 75.0 ± 22.9 and 2.7 ± 2.1 s to a postoperative mean of 20.6 ± 19.7 and 6.3 ± 4.0 s, respectively. The mean GRBAS score improved from preoperative scores of Gpreop  = 2.7, Rpreop  = 2.6, Bpreop  = 2.6, Apreop  = 2.2, and Spreop  = 2.0 to Gpostop  = 0.3, Rpostop  = 0.3, Bpostop  = 0.2, Apostop  = 0.2, and Spostop  = 0.3 at 6 months postoperatively. Improved glottal closure was achieved in all patients (n = 13). Five patients received postoperative adjustment for the optimization of voice quality and glottal closure. No intra- or postoperative complications were observed. Significant improvements in acoustic parameters, including percentage jitter, percentage shimmer, and signal-to-noise ratio, were also observed after MT. All results were statistically significant (P < .05, Cohen's d > .8). CONCLUSIONS: APrevent® VOIS-Implantation is a safe procedure with good voice outcomes. Postoperative adjustments can be performed smoothly to optimize voice quality and glottal closure. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:1622-1629, 2022.

A novel mutation in the WFS1 gene identified in a Taiwanese family with low-frequency hearing impairment.

BACKGROUND: Wolfram syndrome gene 1 (WFS1) accounts for most of the familial nonsyndromic low-frequency sensorineural hearing loss (LFSNHL) which is characterized by sensorineural hearing losses equal to and below 2000 Hz. The current study aimed to contribute to our understanding of the molecular basis of LFSNHL in an affected Taiwanese family. METHODS: The Taiwanese family with LFSNHL was phenotypically characterized using audiologic examination and pedigree analysis. Genetic characterization was performed by direct sequencing of WFS1 and mutation analysis. RESULTS: Pure tone audiometry confirmed that the family members affected with LFSNHL had a bilateral sensorineural hearing loss equal to or below 2000 Hz. The hearing loss threshold of the affected members showed no progression, a characteristic that was consistent with a mutation in the WFS1 gene located in the DFNA6/14/38 locus. Pedigree analysis showed a hereditarily autosomal dominant pattern characterized by a full penetrance. Among several polymorphisms, a missense mutation Y669H (2005T>C) in exon 8 of WFS1 was identified in members of a Taiwanese family diagnosed with LFSNHL but not in any of the control subjects. CONCLUSION: We discovered a novel heterozygous missense mutation in exon 8 of WFS1 (i.e., Y669H) which is likely responsible for the LFSNHL phenotype in this particular Taiwanese family.

Comparison of hearing screening programs between one step with transient evoked otoacoustic emissions (TEOAE) and two steps with TEOAE and automated auditory brainstem response.

OBJECTIVE: To compare the efficacy between one step with transient evoked otoacoustic emissions (TEOAE) and two steps with TEOAE and automated auditory brainstem response (AABR) in a newborn hearing screening program. We investigated their differences in referral rate, the accurate identification rate of congenital hearing loss (HL), and cost effectiveness. METHOD: From November 1998 to December 2004, a total of 21,273 healthy newborns were screened for HL in Mackay Memorial Hospital, Taipei. In the periods from November 1998 to January 2004 and from February 2004 to December 2004, the screening tools used were TEOAE alone (n = 18,260) and TEOAE plus AABR (n = 3,013), respectively. RESULTS: A statistically significant decrease of referral rate was achieved in the group using TEOAE and AABR as screening tools when compared with TEOAE alone (1.8% vs. 5.8%). The accurate identification rate of congenital HL was 0.45% in TEOAE protocol and 0.3% in TEOAE and AABR protocol, which was not statistically significant. The total direct costs per screening were 10.1 U.S. dollars for the program using TEOAE alone and 8.9 U.S. dollars for the TEOAE plus AABR program. The intangible cost, however, was much higher in the earlier program because of the higher referral rate. CONCLUSION: In terms of the efficacy of a hearing screening program using the one step TEOAE and two step TEOAE and AABR programs, the later significantly decreased the referral rate from 5.8% to 1.8%. No significant difference was noted between the accurate identification rates of congenital HL. The total costs, including expenditures and intangible cost, were lower in the protocol with TEOAE plus AABR.

Effectiveness of intratympanic dexamethasone injection in sudden-deafness patients as salvage treatment.

OBJECTIVE: To study the effectiveness of intratympanic dexamethasone (IT-DEX) in patients with severe or profound sudden sensorineural hearing loss (SSNHL) after treatment failure with conventional therapy. STUDY DESIGN: Randomized, controlled study. METHODS: Patients who met the criteria for SSNHL, with a severity of severe to profound, underwent 10 days of standard treatment with oral steroid and other facilitating agents. Patients showing poor response to standard treatment were assigned randomly to a control group or to a group receiving IT-DEX. IT-DEX injections were performed once a week for 3 consecutive weeks. Pure-tone audiometry was obtained before each injection. Minimum follow-up time was 1 month. Successful treatment was defined as a hearing improvement of greater than 30 dB. RESULTS: Thirty-nine patients meeting the inclusion criteria were studied. After treatment with oral steroid, 10 of 39 (26%) patients demonstrated hearing improvement, whereas the remaining 29 (74%) patients showed a hearing improvement of less than 30 dB. For those without hearing improvement, 15 received IT-DEX, and 14 received further standard treatment (except oral steroid and carbogen inhalation). Hearing improved in 8 of 15 (53.3%) compared with 1 of 14 (7.1%), with an average decrease in threshold of 28.4 dB and 13.2 dB for the IT-DEX group and the control group, respectively (P <.05). Prognostic factors such as age, treatment delay time, and sex did not significantly affect the response to therapy. CONCLUSIONS: IT-DEX injection effectively improves hearing in patients with severe or profound SSNHL after treatment failure with standard therapy and is not associated with major side effects. It is therefore a reasonable alternative as salvage treatment.