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Long-Term Effects of Hearing Aids on Hearing Ability in Patients with Sensorineural Hearing Loss

Goel, Anurag R; Bruce, Haley A; Williams, Nicholas; Alexiades, George
BACKGROUND: A frequent concern surrounding amplification with hearing aids for patients with sensorineural hearing loss is whether these devices negatively affect hearing ability. To date, there have been few studies examining the long-term effects of amplification on audiometric outcomes in adults. PURPOSE/OBJECTIVE: In the present study, we examined how hearing aids affect standard audiometric outcomes over long-term periods of follow-up. RESEARCH DESIGN/METHODS: We retrospectively collected audiometric data in adults with sensorineural hearing loss, constructing a model of long-term outcomes. STUDY SAMPLE/METHODS: This retrospective cohort study included 802 ears from 401 adult patients with bilateral sensorineural hearing loss eligible for amplification with hearing aids at a single institution. INTERVENTION/METHODS: Of the eligible patients, 88 were aided bilaterally, and 313 were unaided. DATA COLLECTION AND ANALYSIS/METHODS:), and word recognition score (WRS) per-ear at each encounter. We then modeled the association between the use of hearing aids for 5 years and these audiometric outcomes using targeted maximum likelihood estimation. RESULTS: < 0.001), adjusting for measured confounders. CONCLUSION/CONCLUSIONS:, and WRS, suggesting a greater decline in hearing ability in patients using hearing aids. Future studies are needed to examine these effects between treatment groups over longer periods of time and in more heterogeneous populations to improve clinical practice guidelines and safety of both prescriptive fitting nonprescriptive amplification.
PMID: 34082459
ISSN: 2157-3107
CID: 4891952

Comparison of Cochlear Implant Device Fixation-Well Drilling Versus Subperiosteal Pocket. A Cost Effectiveness, Case-Control Study

Stern Shavit, Sagit; Weinstein, Emery P; Drusin, Madeleine A; Elkin, Elena B; Lustig, Lawrence R; Alexiades, George
OBJECTIVE:To compare surgical characteristics and complications between well drilling (WD) and subperiosteal pocket techniques (SPT) for receiver/stimulator (R/S) fixation of cochlear implant (CI), and conduct cost-effectiveness analysis. STUDY DESIGN/METHODS:Retrospective clinical study, decision-analysis model. SETTING/METHODS:Tertiary referral center. PATIENTS/METHODS:Three-hundred and eighty-eight CI recipients with a minimum of 6-months follow-up. INTERVENTIONS/METHODS:CI surgery using either WD or SPT for R/S fixation. A decision-analysis model was designed using data from a systematic literature review. MAIN OUTCOME MEASURES/METHODS:Surgical operation time, rates of major and minor long-term complications were compared. Incremental cost-effectiveness was also estimated, comparing the two methods of fixation. RESULTS:We compared 179 WD with 209 SPT. Surgery time was significantly shorter in SPT (148 versus 169 min, p = 0.001) and remained significant after adjustment for possible confounders. Higher rates of major complications requiring surgical intervention were found with SPT (10.5% versus 4.5%, p = 0.042), however, the difference was not significant after adjusting for follow-up time (47.8 versus 32.5 months for SPT, WD respectively; p < 0.001). The incremental cost-effectiveness ratio for WD (compared with SPT) was $48,795 per major complication avoided, which was higher than the willingness-to-pay threshold of $47,700 (average cost of 2 h revision surgery). CONCLUSIONS:SPT was found to be faster but potentially risks more complications, particularly relating to device failure. Further long-term studies are required to validate these differences. Based on data from the current literature, neither of the methods is compellingly cost-effective over the other, and surgeons can base their choice on personal preference, comfort, and previous training.
PMID: 33710991
ISSN: 1537-4505
CID: 4809642

Comparison of Speech Performance in Bimodal versus Bilateral Cochlear Implant Users

Sturm, Joshua J; Kuhlmey, Megan; Alexiades, George; Hoffman, Ronald; Kim, Ana H
OBJECTIVE:To assess whether listening with two cochlear implants (bilateral) offers significant benefits in terms of speech perception over listening with one cochlear implant and one hearing aid (bimodal). METHODS:Retrospective review of bilateral cochlear implant recipients (24 pediatric and 26 adult). Bimodal listening was compared to bilateral listening in terms of speech perception performance at 1-year post second implant under three listening conditions: 50 dBHL, 35 dBHL, and 50 dBHL+5 SNR. Changes in speech performance from bimodal (before second implant) to bilateral (after second implant) listening were determined within subjects and compared to a separate control group of bimodal users matched for age of first implantation who never received a second implant (10 pediatric and 20 adult). RESULTS:In the pediatric group, compared to bimodal listening prior to a second implant, speech perception scores with bilateral implants increased significantly when measured at 50 dBHL, 35 dBHL, and 50 dBHL+5 SNR. By contrast, pediatric bimodal controls who never received a second implant failed to demonstrate similar improvement over 1 year's time. In the adult group, compared to bimodal listening prior to a second implant, speech perception scores with bilateral implants increased when measured at 50 dBHL, but were not significantly different at 35 dBHL and 50 dBHL + 5 SNR. Adult bimodal controls who never received a second implant failed to demonstrate significant improvement in all conditions over 1 year's time. CONCLUSION/CONCLUSIONS:Bilateral listening with two cochlear implants improved speech perception performance relative to bimodal listening in the pediatric population. Improvement in the adult population was not as significant. LEVEL OF EVIDENCE/METHODS:4, Retrospective Chart Review. Laryngoscope, 2020.
PMID: 32876332
ISSN: 1531-4995
CID: 4583332

Venous sinus stenting for the treatment of isolated pulsatile tinnitus: Results of a prospective trial

Patsalides, Athos; Santillan, Alejandro; Sundararajan, Sri Hari; Michael, Marissa; Suurna, Maria; Alexiades, George
OBJECTIVES/OBJECTIVE:This prospective study evaluates the effectiveness and safety of venous sinus stenting for patients with isolated pulsatile tinnitus and lateral sinus stenosis. METHODS:Patients with isolated pulsatile tinnitus and lateral sinus stenosis with a minimum trans stenotic gradient of 4 mm Hg were treated with stenting. Pulsatile tinnitus before and after treatment was assessed with the Tinnitus Handicap Inventory (THI). Periprocedural adverse events, neurological complications, clinical and radiographic follow-up were also recorded. RESULTS:A total of 42 patients (41 females and 1 male) were included in the study (median age of 37.5 years). Thirty patients had post-stenotic fusiform and 12 had post-stenotic saccular venous sinus aneurysm. In addition to stenting, coils were used to treat the patients with saccular venous aneurysms. The median follow-up was 5 months (range 1 to 34 months). Most patients had complete (39/42) or near-complete (2/42) resolution of their pulsatile tinnitus post-procedure. There were no serious adverse events. CONCLUSION/CONCLUSIONS:Stenting of the lateral venous sinus is a safe and effective treatment for patients with isolated pulsatile tinnitus due to venous sinus stenosis.
PMID: 33243042
ISSN: 2385-2011
CID: 4680982

Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes

Pillsbury, Harold C; Dillon, Margaret T; Buchman, Craig A; Staecker, Hinrich; Prentiss, Sandra M; Ruckenstein, Michael J; Bigelow, Douglas C; Telischi, Fred F; Martinez, Diane M; Runge, Christina L; Friedland, David R; Blevins, Nikolas H; Larky, Jannine B; Alexiades, George; Kaylie, David M; Roland, Peter S; Miyamoto, Richard T; Backous, Douglas D; Warren, Frank M; El-Kashlan, Hussam K; Slager, Heidi K; Reyes, Carisa; Racey, Allison I; Adunka, Oliver F
OBJECTIVE:To demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic Stimulation (EAS) System, for adults with residual low-frequency hearing and severe-to-profound hearing loss in the mid to high frequencies. STUDY DESIGN/METHODS:Prospective, repeated measures. SETTING/METHODS:Multicenter, hospital. PATIENTS/METHODS:Seventy-three subjects implanted with PULSAR or SONATA cochlear implants with FLEX electrode arrays. INTERVENTION/METHODS:Subjects were fit postoperatively with an audio processor, combining electric stimulation and acoustic amplification. MAIN OUTCOME MEASURES/METHODS:Unaided thresholds were measured preoperatively and at 3, 6, and 12 months postactivation. Speech perception was assessed at these intervals using City University of New York sentences in noise and consonant-nucleus-consonant words in quiet. Subjective benefit was assessed at these intervals via the Abbreviated Profile of Hearing Aid Benefit and Hearing Device Satisfaction Scale questionnaires. RESULTS:Sixty-seven of 73 subjects (92%) completed outcome measures for all study intervals. Of those 67 subjects, 79% experienced less than a 30 dB HL low-frequency pure-tone average (250-1000 Hz) shift, and 97% were able to use the acoustic unit at 12 months postactivation. In the EAS condition, 94% of subjects performed similarly to or better than their preoperative performance on City University of New York sentences in noise at 12 months postactivation, with 85% demonstrating improvement. Ninety-seven percent of subjects performed similarly or better on consonant-nucleus-consonant words in quiet, with 84% demonstrating improvement. CONCLUSION/CONCLUSIONS:The MED-EL EAS System is a safe and effective treatment option for adults with normal hearing to moderate sensorineural hearing loss in the low frequencies and severe-to-profound sensorineural hearing loss in the high frequencies who do not benefit from traditional amplification.
PMID: 29342054
ISSN: 1537-4505
CID: 2988242

Method to Estimate the Complete and Two-Turn Cochlear Duct Length

Alexiades, George; Dhanasingh, Anandhan; Jolly, Claude
HYPOTHESIS: Using a linear measurement of the cochlea on a single radiographic image can reliably estimate the complete and two-turn cochlear duct length (CDL) in a normal human temporal bone. BACKGROUND: CDL is measured from the middle of the round window to the helicotrema. Histologic studies have shown the length of the organ of Corti (OC) to range from 25 to 35 mm. CDL measurements, performed either radiographically or histologically, are quite tedious and time-consuming. We propose equations that can reliably estimate both two-turn and complete CDL using a single computed tomography (CT) image. METHODS: Prior studies of CDL, measured either histologically or radiographically, were reviewed, which yielded distributions of CDL measured at the OC and the lateral wall of the cochlea. Using Escude's third equation as a basis, we were able to extrapolate complete and two-turn CDL based on a CT scan measurement of the diameter of the basal turn (A). RESULTS: Using measurement A, the relationship of two-turn CDL measured at the OC is 2TL(oc) = 3.65(A-1) and for 2TL(i) = 3.65(A-0.7). The equation for estimation of complete CDL is CDL(oc) = 4.16A - 4 and for CDL(i) = 4.16A - 2.7. CONCLUSION: Using a single linear measurement from a CT scan image can reliably estimate the two-turn and complete CDLs in human temporal bones. The two-turn length represents the best compromise of cochlear coverage while minimizing intracochlear trauma for electrode insertions.
PMID: 25299827
ISSN: 1531-7129
CID: 1472082

Diagnostic and prognostic utility of measuring tumor necrosis factor in the peripheral circulation of patients with immune-mediated sensorineural hearing loss

Svrakic, Maja; Pathak, Shresh; Goldofsky, Eliot; Hoffman, Ronald; Chandrasekhar, Sujana S; Sperling, Neil; Alexiades, George; Ashbach, Matthew; Vambutas, Andrea
OBJECTIVES: To characterize levels of tumor necrosis factor (TNF; formerly known as tumor necrosis factor alpha), a well-established proinflammatory cytokine, in patients with immune-mediated sensorineural hearing loss (IM-SNHL) and to determine the role of this cytokine in identifying steroid-responsive hearing loss. DESIGN: Prospective case-control study. SETTING: Tertiary care academic medical center. PATIENTS: A total of 11 control subjects and 85 patients with clinical and audiometric characteristics of IM-SNHL (autoimmune inner ear disease and sudden SNHL combined) treated with corticosteroids were enrolled in the study. Patients were categorized as steroid responders (n = 47) and steroid nonresponders (n = 38). Peripheral venous blood was used to determine the total amount of plasma TNF by enzyme-linked immunosorbent assay. Peripheral blood mononuclear cells (PBMCs) were isolated and treated with in vitro dexamethasone. Treated and untreated PBMCs were then analyzed for release of soluble TNF protein into conditioned supernatants as well as expression of TNF messenger RNA (mRNA). MAIN OUTCOME MEASURES: Mean plasma levels of TNF, unstimulated and dexamethasone-stimulated PBMC-secreted levels of TNF, and TNF mRNA levels in unstimulated and dexamethasone-stimulated PBMCs. RESULTS: Steroid nonresponders had the highest mean baseline plasma levels of TNF compared with steroid responders and control subjects (27.6, 24.1, and 14.4 pg/mL, respectively) (P = .03). For patients with IM-SNHL with a high baseline plasma levels of TNF (>14.4 pg/mL), the mean TNF secreted by PBMCs was 59.1 pg/mL, which decreased to 7.2 pg/mL with in vitro dexamethasone stimulation in the responder group, while the mean TNF secreted by PBMCs was 11.2 pg/mL, which slightly increased to 11.7 pg/mL with in vitro dexamethasone stimulation in the nonresponder group (P = .04). CONCLUSIONS: The level of TNF can be used as both a diagnostic and prognostic cytokine for IM-SNHL. For patients presenting with a sudden change in hearing threshold, a high baseline plasma TNF from the peripheral circulation is supportive of the diagnosis if it is greater than 18.8 pg/mL, with a positive predictive value higher than 97%. In addition, this study demonstrates that for patients with IM-SNHL and high plasma levels of TNF, their clinical response to oral glucocorticoids can be predicted by their in vitro PBMC response to dexamethasone. This algorithm may further guide optimal medical treatment and possibly avoid the deleterious adverse effects of administering glucocorticoids to those patients who would not benefit from their effect.
PMID: 23165380
ISSN: 0886-4470
CID: 1472092

Revision cochlear implant surgery in patients with suspected soft failures

Chung, Doug; Kim, Ana H; Parisier, Simon; Linstrom, Christopher; Alexiades, George; Hoffman, Ronald; Kohan, Darius
OBJECTIVE: To review our patient series who underwent revision cochlear implantation surgery, with special emphasis on the 'soft failure' group. STUDY DESIGN: Retrospective chart review of cochlear implant revision surgeries from 1979 to 2008. An extensive review of these patients' medical, audiologic, and radiographic histories was performed. SETTING: Two tertiary care hospitals and 1 academic cochlear implant center. INTERVENTION: Explantation and reimplantation of cochlear implant, explanted device analysis, speech perception testing. MAIN OUTCOME MEASURES: Postoperative speech performance. RESULTS: Approximately 1,500 cochlear implant surgeries were performed from 1979 to 2008. Of these, 113 (7.53%) procedures in 98 patients were revision cases. The underlying reason for revision surgery was divided into 4 categories: 26 hard failures (23%), 31 medical failures (27.4%), 14 soft failures (12.4%), and 42 (37.2%) not classified/ambiguous cases. The last group was not categorized because of lack of available medical documentation or because of an ambiguous device failure analysis. The top 3 most common causes of hard failure were loss of hermiticity (8 patients [30.8%]), Vendor B defects (7 patients [26.9%]), and cracked casing (4 patients [15.4%]). The most common cause of medical failure was device extrusion (11 patients [35.5%]) followed by head trauma to the site of implantation (11 patients [35.5%]), and wound infection (5 patients [16.1%]). Fourteen patients (14.2%) were categorized as soft failures. All soft failure patients demonstrated a deterioration in pure-tone average and speech perception. Of the soft failure group, time to revision surgery was 4.7 years in contrast to 4.2 years for the hard failure group and 4.3 years for all revisions. An extensive review of patients' medical histories showed that 4 (28.5%) of the 14 patients had a previous diagnosis of meningitis. Two patients (14.3%) had evidence of inner ear malformations, and 2 patients (14.3%) had history of asthma. CONCLUSION: Our cochlear revision series are comparable to what is reported in the literature. However, an unexpected relationship between meningitis was identified among our soft failure group. More than one-quarter carried a history of meningitis. Moreover, nearly one-half of all soft failures had some form of inflammatory derangement. We used the soft failure criteria established by the 2005 Consensus Development Conference for our population analysis. Although we agree that audiologic data often are essential for defining soft failure, multiple patients in our series experienced pain that was severe enough to prevent a complete audiometric evaluation, therefore not rigorously fulfilling the criteria set forth by the 2005 Consensus. However, because their symptoms resolved after reimplantation, and their speech performance restored, we propose modifications of the current definition of 'soft failure' to include these patients
PMID: 20729777
ISSN: 1537-4505
CID: 145704

Otologics fully implantable hearing system: Phase I trial 1-year results

Jenkins, Herman A; Atkins, James S; Horlbeck, Drew; Hoffer, Michael E; Balough, Ben; Alexiades, George; Garvis, William
OBJECTIVE: To assess the safety of the Otologics fully implantable hearing system after 1 year of use in a Phase I clinical trial. STUDY DESIGN: Repeated-measures within-subjects design. SETTING: Procedures were performed in a variety of facilities, including a university, military, and private hospital's ambulatory surgical center and outpatient clinical audiologic test facilities. PATIENTS: Adult patients with bilateral moderate to severe sensorineural hearing loss. INTERVENTION(S): Surgical insertion of this prosthesis included an atticotomy to expose the incus, securing the transducer to the mastoid bone, attaching the transducer tip to the incus via insertion into a laser-drilled hole, and postauricular implantation of the microphone/battery/electronics capsule. MAIN OUTCOME MEASURE(S): Subjective patient benefit, aided sound field thresholds, and speech discrimination with the subject's own, appropriately fit, walk-in hearing aid(s) and the prosthesis were assessed. RESULTS: There were no pre-post-implant differences noted for bone conduction: slight differences were noted in the pre-post-implant air conduction results (p < 0.05). These differences were attributed to the healing process and reversed to almost preimplant assessment levels by the third-month evaluation. Pure-tone averages and monaural word recognition scores were slightly better for the walk-in-aided condition (p < 0.05), whereas the patient benefit scales favored the postoperative implant-aided conditions.Adverse effects of the implant were encountered on 14 occasions after the implantation of the 20 subjects. With the exception of partial device extrusions (that occurred later), all were rectified by the time of initial activation. At the 12-month data collection point, problems that had been encountered by subjects included 1) partial device extrusion (3 subjects), necessitating explantation in 2; 2) loss of external communication (2 subjects), resulting in 1 explantation; and 3) increased charging times beyond 1.5 hours (7), resulting in 3 explantations and 2 patients not using their device while awaiting explantation. CONCLUSION: Phase I trial results provide evidence that this fully implantable device can provide sound amplification to sensorineural hearing loss patients, with performance results similar to the patients' walk-in hearing aids.
PMID: 18317397
ISSN: 1531-7129
CID: 1472102

Glomus Tumors in Patients of Advanced Age: A Conservative Approach

Cosetti, Maura; Linstrom, Christopher; Alexiades, George; Tessema, Belachew; Parisier, Simon
OBJECTIVES:: Identify and discuss controversies in the management of paragangliomas in elderly patients.Assess and evaluate a conservative treatment strategy involving limited surgical resection and vigilant monitoring of the outcome measures of tumor control, peritreatment morbidity, symptom resolution, and hearing preservation. STUDY DESIGN:: Retrospective case review. METHODS:: All of the patients in this study were over age 60 with temporal bone glomus tumors. Primary outcome assessment included length of hospitalization, perioperative morbidity, symptom resolution, hearing preservation, and long-term tumor control. RESULTS:: Twelve female patients with mean age of 74.5 years (range 61-85 years) with follow-up from 24 months to 33 years (mean/median: 5/7.8 years) were identified. Nine (75%) of the patients presented with pulsatile tinnitus.Seven patients (58%) underwent surgical excision of the middle ear component of the paraganglioma. Tumors extending to the jugular foramen were purposely not resected. Five patients (45%) had relative or absolute contraindications to surgical resection and were treated with observation or primary radiation therapy. Post-treatment audiometric evaluation confirmed stable or improved hearing. Pulsatile tinnitus resolved in all patients. No patient experienced cranial nerve deficits, extended hospitalization, or blood transfusions.All patients were followed closely with radiological imaging. The majority of patients demonstrated no disease or stable disease, while two patients demonstrated tumor growth 6 years after diagnosis. CONCLUSION:: A prolonged natural history and the morbidity associated with surgical intervention have led to controversies in the treatment of glomus tumors in an elderly population. Our experience supports recent limited reports advocating conservative surgical excision and vigilant long-term monitoring in this population
PMID: 18030172
ISSN: 0023-852x
CID: 74780