Adverse events associated with Vibrant Soundbridge: A MAUDE study.

OBJECTIVE: To summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. MATERIALS AND METHODS: The FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. RESULTS: Six hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). CONCLUSIONS: Despite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

The impact of menopausal status on auditory brainstem responses.

OBJECTIVE: To determine the effect of decreased estrogen levels due to menopause on auditory brainstem response measurements (ABR). STUDY DESIGN: Retrospective chart review. SETTING: Academic. PATIENTS: Pre- and post-menopausal females (pre-M, post-M) and age-matched males. METHODS: ABR measurements of wave I, III, and V latencies, and interpeak latencies; amplitudes of waves I, III, V, and V/I ratio. OUTCOME MEASURE: Differences in ABR measurements between pre-M and post-M. RESULTS: 164 subjects (101 female and 64 male) were included. Post-M had significantly greater latencies (msec) than pre-M of wave V. Post-M had a significantly smaller wave I amplitude (uV) than pre-M. Post-M had a significantly higher wave V/I amplitude ratio than pre-M. Pre-M had significantly shorter latencies than young males for wave III, and wave V. Post-M had significantly shorter latencies than older males at wave III, and wave V. A two-way ANOVA revealed a significant interaction between the effects of age category and gender on V/I amplitude. CONCLUSION: Post-M group showed a significant drop in wave I amplitude compared with pre-M group, even in the absence of hearing loss, suggesting that the gender differences in hearing are related to estrogen signaling along the auditory pathway. If wave I amplitude changes between older and younger groups resulted from decreased peripheral hearing sensitivity, we would expect larger drops in amplitude in males since rates of presbycusis are higher. We observed much larger drops in wave I amplitude in females, which cannot be attributed to peripheral hearing loss. These results may assist in understanding gender differences in presbycusis and a possible protective effect of estrogen on the auditory system. Knowledge of gender differences in wave I may be important when ABR is used to assess possible synaptopathy.

Prevalence of Objective Voice Measurement Use in Laryngology Practices in the United States.

OBJECTIVES: The aim of this study was to assess the prevalence of use of objective voice measurements (OVM), instrumentation, and factors that may impact OVM outcomes, such as setting and implementation to clarify current practice. Doing so should clarify the impact of OVM research on patient care. METHODS: A 12-question, one-time anonymous survey using the Research Electronic Data Capture tool was distributed during January 2023 to laryngologists in the United States identified through membership in The Voice Foundation (TVF) or previous participation in a TVF symposium. RESULTS: A total of 101 responses to 418 emails yielded a response rate of 24.2%. Seventeen point eight percentage (N = 18) were in private practice, 63.4% (N = 64) were in academic settings, and 18.8% (N = 19) were classified as mixed private and academic. Common OVMs used were fundamental frequency 95.12% (N = 78), maximum phonation time 90.24% (N = 74), noise-to-harmonic ratio 71.95% (N = 59), jitter 71.95% (N = 59), and shimmer 70.73% (N = 58). Common equipment and software used Pentax Multi-Dimensional Voice Program 42.68% (N = 35), Pentax Computerized Speech Lab Model 4500B 37.80% (N = 31), and Pentax Visi-Pitch, Model 3950C 23.17% (N = 19), PRAAT 21.95% (N = 18), OperaVOX 4.88% (N = 4), VoceVista 3.66% (N = 3). Fifty one point two percentage (N = 42) stated that they used OVMs with the majority of their patients, most commonly for the assessment of treatment effectiveness (84.1%, N = 69), documentation (78.0%, N = 64), research (70.7%, N = 58), and/or diagnosis (61.0%, N = 50). Ninety point two percentage (N = 74) stated that OVMs were used during initial evaluation of patients. CONCLUSION: This study estimates of the prevalence of OVM use among laryngologists in the United States. There appears to be sufficient consistency among laryngology centers to permit comparison of results between centers, although additional research is needed. Future OVM research should compare measurements and equipment commonly used by laryngologists to define further the generalizability of results.

Otolaryngology resident familiarity with surgical instruments and preoperative setup: A pilot study.

OBJECTIVE: This study was designed to determine otolaryngology (ORL) residents' ability to prepare the operating room independently for ORL surgical cases and their familiarity with ORL surgical instruments and related equipment. METHODS: A 24-question, one-time, anonymous survey was distributed to otolaryngology-head and neck surgery program directors for distribution among their residents in the United States in November 2022. Residents in every post-graduate year were surveyed. Spearman's ranked correlation and Mann-Whitney U test were used. RESULTS: The response rate among program directors was 9.5 % (11/116 programs), while the response rate among residents was 51.5 % (88/171 residents). A total of 88 survey responses were completed. 61 % of ORL residents who responded were able to name most instruments used in surgical cases. The most recognized surgical instruments by ORL residents were microdebrider (99 %) and alligator forceps (98 %); the least recognized were bellucci micro scissors (72 %) and pituitary forceps (52 %); and all instruments except the microdebrider showed significantly increased recognition with increasing post graduate training year (PGY), p ≤ 0.05. ORL residents were most able to set up independently the electrocautery (77 %) and laryngoscope suspension (73 %), while they were least able to set up the robot laser (6.8 %) and coblator (26 %) independently. All instruments showed significant positive correlations with increasing PGY; the strongest correlation was found in laryngoscope suspension, r = 0.74. 48 % of ORL residents reported that there were times when surgical techs and nurses were not available. Only 54 % of ORL residents reported being able to set up instruments when alone in the operating room, including 77.8 % of PGY-5 residents. Only 8 % of residents reported receiving education related to surgical instruments from their residency program, while 85 % thought that ORL residencies should have courses or educational materials about surgical instruments. CONCLUSION: ORL residents' familiarity with surgical instruments and preoperative setup improved throughout their training. However, specific instruments had much lower recognition than others and a lower ability for independent setup. Nearly half of ORL residents reported being unable to set up surgical instruments in the absence of surgical staff. Implementation of surgical instrument education may improve these deficiencies.

Assessing the Prevalence and Associated Risk Factors for Presbylarynx in the Elderly Laryngology Population.

OBJECTIVE: The primary objective of this study was to assess the prevalence of presbylarynx and its associated features in an elderly population representative of patients seen in a tertiary care laryngology practice. The secondary objective of this study was to compare laryngeal electromyography (LEMG) findings, coexisting VF conditions, medical history, surgical history, medication use, and other parameters between patients with and without presbylarynx. METHODS: Adult voice patients aged 60 years and older who underwent strobovideolaryngoscopy were included in the study. Patients were assigned to one of two groups based on the majority (≥2/3) agreement of three blinded authors' (GA, KL, and HP) graded examinations of strobovideolaryngoscopy (SVL) videos for findings consistent with presbylarynx (atrophic vocal folds [VFA], vocal fold bowing [VFB], vocal process prominence [VPP] and anterior glottic insufficiency [GI]). Patient demographics, medical history, surgical history, medication use, laboratory results, and SVL videos were compiled. Statistical analysis was performed using SPSS 28.0.0.0 (IBM, Armonk, NY). All tests were performed two-tailed, and a P-value of less than 0.05 was considered statistically significant. RESULTS: One hundred sixty-four patients (84 female/80 male, mean age of 68.397 ± 4.947 years) were included in this study. The prevalence of presbylarynx was 52.4% (n = 86) in the study population. The mean age of patients in the presbylarynx group was significantly higher than the nonpresbylarynx group. Additionally, there were significantly more males than females in the presbylarynx group. The presbylarynx group also was found to have a higher proportion of ACE inhibitor (ACEi) use. Further, laboratory results revealed a significantly higher proportion of patients with elevated thyroid stimulating hormone (TSH) levels in the presbylarynx group. Conversely, patients in the nonpresbylarynx group were found to have a significantly higher rate of levothyroxine use. On SVL, patients in the nonpresbylarynx cohort were found to have a significantly higher proportion of benign vocal fold lesions and vocal fold paresis. However, LEMG testing revealed no statistically significant differences in muscle recruitment between groups. Men with presbylarynx were found to have a significantly higher proportion of VFB and VPP compared to women with presbylarynx. CONCLUSION: This retrospective study investigated the prevalence and risk factors associated with presbylarynx in patients representative of those treated by laryngologists. Signs consistent with presbylarynx are observable even in the presence of coexisting VF conditions. Older age, elevated TSH, the use of ACEi, and male gender was associated with signs of presbylarynx on SVL. Of those diagnosed with presbylarynx, males were identified as having higher proportions of VFB and VPP compared to females. More education regarding presbylarynx and further studies to improve standardization of the criteria for its diagnosis, as well as its relationship with other VF conditions, are encouraged to improve management of the aging voice.

The Relationship Between Vocal Fold Mobility Disorders and Ineffective Esophageal Motility.

OBJECTIVE: Deglutition, speech production, and airway protection are extraordinarily complex, interrelated functions that are coordinated, in large part, by the motor and sensory innervation of CN X. Previous studies assessing the relationship between neurogenic voice disorders and dysphagia have focused on the risk of aspiration due to glottic insufficiency and the association of vocal fold hypomobility (VFH) with systemic neurologic disease. The purpose of this study was to investigate the relationship between VFH disorders and ineffective esophageal motility (IEM). METHODS: Adult voice patients who underwent laryngeal electromyography (LEMG) and dual 24-hour pH impedance with high-resolution manometry (HRM) testing were included in the study. Subjects were assigned to one of two groups based on the presence or absence of moderate-to-severe RLN and/or SLN VFH (Mo-SLNH/RLNH) using results from six muscle LEMG tests. In subjects with Mo-SLNH/RLNH, there was 0-60% muscle recruitment on LEMG, whereas control subjects in the non-Mo-SLNH/RLNH group demonstrated 61-100% muscle recruitment. Analysis of mild-to-severe VFH (80% muscle recruitment or less) was also performed in a similar manner. The prevalence of IEM, defined using Chicago Classification Version 4.0 (CCv4.0), was compared between groups, as were HRM parameters. RESULTS: One hundred sixty-two subjects were included (37.7% male/62.3% female, mean age of 43.88 ± 17.285). No differences in IEM prevalence were found when stratifying for cases of mild-to-severe VFH. However, there was significantly higher percentage of IEM in those with Mo-SLNH/RLNH. Mo-SLNH/RLNH subjects demonstrated higher rates of weak swallows and inefficient swallows, as well as lower IBP and UES residual pressures on HRM. CONCLUSIONS: Patients with Mo-SLNH/RLNH demonstrated a significantly higher prevalence of IEM. Those with mild-to-severe VFH did not. Higher rates of ineffective and weak swallows, and lower IBP and UES residual pressures among Mo-SLNH/RLNH subjects suggest a possible connection between Mo-SLNH/RLNH and IEM disorders. These manometric differences were more prominent with sub-stratification of the Mo-SLNH/RLNH group by IEM. Additional research is advised.