Significant improvement in body contour with multiple cycles of CoolSculpting: Results of a prospective study.

Cryolipolysis is a nonsurgical body sculpting technique that uses controlled cooling for localized fat reduction. The aim of the present study was to assess whether an intensive regimen of CoolSculpting based on multiple cycles/sessions on the same body area(s) could yield greater (more clinically significant) improvements in body contour. This was a prospective analysis of consecutive, healthy, adult patients undergoing CoolSculpting in routine practice across a variety of treatment areas. Patients underwent ≤4 cycles of CoolSculpting per body area during an initial treatment session, and ≤4 further cycles 4 weeks later (if required). They were followed up for ≥12 weeks. Twenty-eight patients were enrolled (n = 26 female; mean age: 51.6 ± 9.0 years; mean body weight: 69.4 ± 13.7 kg). They were treated across 58 body areas: 48 in a single session; 10 across two sessions. The mean number of cycles per area was 2.8 ± 1.5. Twenty-seven patients (54 body areas) were considered as treatment "responders." In these individuals, mean skinfold thickness decreased from 35.4 ± 9.9 mm pretreatment to 22.2 ± 7.6 mm at 12 weeks (mean change: -40%; P < .001). Mean change in skinfold thickness was greater with ≥3 vs 1 to 2 cycles of CoolSculpting (P = .01). Patient satisfaction was high (n = 51/58; 88%). No adverse events were recorded. The study shows that multiple cycles/sessions of CoolSculpting can safely improve overall treatment benefit in body contouring, with greater decreases in skinfold thickness than have typically been previously observed.

Group Means and Intersubject and Intrasubject Variability Estimates for Absolute and Relative (Categorical) Loudness Judgments of Typical Young Adult Listeners.

Purpose This brief research note is motivated by an ever-increasing need for typical repeated-measures loudness judgments and variability estimates of the kind necessary to conduct evidence-based treatment studies and clinical trials. Method These judgments and variability data, originally collected but not reported by Formby, Payne, Yang, Wu, and Parton (2017) , are presented here for relative (categorical) and absolute loudness judgments for typical young adult listeners with normal auditory function. Results As shown in this research note, these data may differ appreciably between young and older adult listeners with audiometric pure-tone thresholds within the clinically normal range. Conclusion In general, these findings highlight the need for good age-based, repeated-measures data for planning and powering evidence-based treatment studies and, specifically, for clinical trials that rely on categorical loudness judgments (i.e., as measured with the Contour Test of loudness; Cox, Alexander, Taylor, & Gray, 1997 ) as primary and secondary outcome measures.

Repeated Measurement of Absolute and Relative Judgments of Loudness: Clinical Relevance for Prescriptive Fitting of Aided Target Gains for soft, Comfortable, and Loud, But Ok Sound Levels.

This study was undertaken with the purpose of streamlining clinical measures of loudness growth to facilitate and enhance prescriptive fitting of nonlinear hearing aids. Repeated measures of loudness at 500 and 3,000 Hz were obtained bilaterally at monthly intervals over a 6-month period from three groups of young adult listeners. All volunteers had normal audiometric hearing sensitivity and middle ear function, and all denied problems related to sound tolerance. Group 1 performed judgments of soft and loud, but OK for presentation of ascending sound levels. We defined these judgments operationally as absolute judgments of loudness. Group 2 initially performed loudness judgments across a continuum of seven loudness categories ranging from judgments of very soft to uncomfortably loud for presentation of ascending sound levels per the Contour Test of Loudness; we defined these judgments as relative judgments of loudness. In the same session, they then performed the absolute judgments for soft and loud, but OK sound levels. Group 3 performed the same set of loudness judgments as did group 2, but the task order was reversed such that they performed the absolute judgments initially within each test session followed by the relative judgments. The key findings from this study were as follows: (1) Within group, the absolute and relative tasks yielded clinically similar judgments for soft and for loud, but OK sound levels. These judgments were largely independent of task order, ear, frequency, or trial order within a given session. (2) Loudness judgments increased, on average, by ∼3 dB between the first and last test session, which is consistent with the commonly reported acclimatization effect reported for incremental changes in loudness discomfort levels as a consequence of chronic bilateral hearing aid use. (3) Measured and predicted comfortable judgments of loudness were in good agreement for the individual listener and for groups of listeners. These comfortable judgments bisect the measured levels judged for soft and for loud, but OK sounds. (4) Loudness judgments within the same loudness category varied across listeners within group by as much as 50 to 60 dB. Such large variation in judgments of loudness is problematic, especially because hearing-impaired listeners are known to exhibit similarly large ranges of intersubject response variation and, yet, poplar prescriptive fitting strategies continue to use average rather than individual loudness data to fit nonlinear hearing aids. The primary conclusions drawn from these findings are that reliable absolute judgments of soft and loud, but OK are clinically practical and economical to measure and, from these judgments, good estimates of comfortable loudness can also be predicted for individuals or for groups of listeners. Such loudness data, as measured as described in this report, offer promise for streamlining and enhancing prescriptive fitting of nonlinear hearing aids to target gain settings for soft (audible), comfortable, and loud, but OK (tolerable) sound inputs for the individual listener.

A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial.

The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy-based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis among patients with tinnitus, were evaluated in this study in a target sample of unsuccessfully fit and/or problematic prospective hearing aid users with diminished DRs (owing to their elevated audiometric thresholds and reduced sound tolerance). Secondary aims included: (1) delineation of the treatment contributions from the counseling and sound therapy components to the full-treatment protocol and, in turn, the isolated treatment effects from each of these individual components to intervention success; and (2) characterization of the respective dynamics for full, partial, and control treatments. Thirty-six participants with bilateral sensorineural hearing losses and reduced DRs, which affected their actual or perceived ability to use hearing aids, were enrolled in and completed a placebo-controlled (for sound therapy) randomized clinical trial. The 2 × 2 factorial trial design was implemented with or without various assignments of counseling and sound therapy. Specifically, participants were assigned randomly to one of four treatment groups (nine participants per group), including: (1) group 1-full treatment achieved with scripted counseling plus sound therapy implemented with binaural sound generators; (2) group 2-partial treatment achieved with counseling and placebo sound generators (PSGs); (3) group 3-partial treatment achieved with binaural sound generators alone; and (4) group 4-a neutral control treatment implemented with the PSGs alone. Repeated measurements of categorical loudness judgments served as the primary outcome measure. The full-treatment categorical-loudness judgments for group 1, measured at treatment termination, were significantly greater than the corresponding pretreatment judgments measured at baseline at 500, 2,000, and 4,000 Hz. Moreover, increases in their "uncomfortably loud" judgments (∼12 dB over the range from 500 to 4,000 Hz) were superior to those measured for either of the partial-treatment groups 2 and 3 or for control group 4. Efficacy, assessed by treatment-related criterion increases ≥ 10 dB for judgments of uncomfortable loudness, was superior for full treatment (82% efficacy) compared with that for either of the partial treatments (25% and 40% for counseling combined with the placebo sound therapy and sound therapy alone, respectively) or for the control treatment (50%). The majority of the group 1 participants achieved their criterion improvements within 3 months of beginning treatment. The treatment effect from sound therapy was much greater than that for counseling, which was statistically indistinguishable in most of our analyses from the control treatment. The basic principles underlying the full-treatment protocol are valid and have general applicability for expanding the DR among individuals with sensorineural hearing losses, who may often report aided loudness problems. The positive full-treatment effects were superior to those achieved for either counseling or sound therapy in virtual or actual isolation, respectively; however, the delivery of both components in the full-treatment approach was essential for an optimum treatment outcome.

Reliability and diagnostic accuracy of clinical tests of vestibular function for children.

PURPOSE: To determine reliability, diagnostic values, and minimal detectable change scores, 90% confidence (MDC90) of pediatric clinical tests of vestibular function. METHODS: Twenty children with severe to profound bilateral sensorineural hearing loss and 23 children with typical development, aged 6 to 12 years, participated. The Head Thrust Test, Emory Clinical Vestibular Chair Test, Bucket Test, Dynamic Visual Acuity, Modified Clinical Test of Sensory Interaction on Balance, and Sensory Organization Test were completed twice for reliability. Reference standard diagnostic tests were rotary chair and vestibular evoked myogenic potential. Reliability, sensitivity, specificity, predictive values, likelihood ratios, and MDC90 scores were calculated. RESULTS: Reliability ranged from an intraclass correlation coefficient of 0.73 to 0.95. Sensitivity, specificity, and predictive values, using cutoff scores for each test representing the largest area under the curve, ranged from 63% to 100%. The MDC90 for Dynamic Visual Acuity and Modified Clinical Test of Sensory Interaction on Balance were 8 optotypes and 16.75 seconds, respectively. CONCLUSIONS: Clinical tests can be used accurately to identify children with vestibular hypofunction.