Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids.

Importance: With rising interest in over-the-counter (OTC) hearing aids as an alternative to traditional audiologist-fit devices, understanding their long-term efficacy is crucial. However, given the novelty of the US Food and Drug Administration category of OTC hearing aids, minimal evidence currently supports their long-term efficacy. Objective: To compare the long-term self-reported outcomes at 8 months of self-fit OTC hearing aids to the same hearing aids fit by audiologists. Design, Setting, and Participants: Building on a previous randomized clinical trial, this follow-up comparative effectiveness research study reassessed a number of the original participants that were not lost to follow-up. Participants were initially divided into those with self-fit OTC hearing aids and those with audiologist-fit devices. Approximately 8 months after fitting, participants completed self-reported questionnaires. Missing data were addressed through multiple imputation. The original noninferiority trial was conducted at the University of Pretoria in South Africa from April 2022 to August 2022. The current analysis took place between July 7, 2023, to November 20, 2023. Interventions: In the original trial, participants in the self-fit device group received a pair of OTC hearing aids and independently fit them with remote support as needed. The audiologist-fit device group received the same hearing aids fit by a certified audiologist using best practices. Main Outcomes and Measures: The main outcomes were self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the International Outcome Inventory for Hearing Aids (IOI-HA). Results: Of 64 participants in the trial, 44 participants were included in the extension study (21 [47.7%] in the audiologist-fit group; 23 [52.3%] in the self-fit group). The mean (SD) age of these participants was 63.0 (13.2) years, and 21 (47.7%) were male. At the long-term follow-up, self-fit and audiologist-fit groups showed no significant differences in the APHAB global score (mean difference, 0.02 [95% CI, -7.1 to 7.1]; Cohen d, 0.01 [95% CI, -0.5 to 0.5]) or the IOI-HA total score (mean difference, 1.5 [95% CI, -1.4 to 4.4]; Cohen d, 0.3 [95% CI, -0.2 to 0.8]). From 6 weeks to 8 months, no clinically meaningful group-time interaction was found between groups for the APHAB global score (Cohen d, 0.1 [95% CI, -0.2 to 0.3]), but a significant interaction for the IOI-HA total score was found (Cohen d, -0.6 [95% CI, -0.8 to -0.3]), with the self-fit group generally performing better. Conclusion: This comparative effectiveness research study demonstrated that self-fit OTC hearing aids can offer comparable long-term benefits to audiologist-fit hearing aids for individuals with mild to moderate hearing loss.

Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial.

Importance: Fewer than 20% of US adults with hearing loss use hearing aids due to barriers like high cost. Over-the-counter (OTC) hearing aids offer a potential solution, incorporating self-fitting strategies via smartphone apps. Self-fitting strategies have been validated for Food and Drug Administration (FDA)-approved OTC hearing aids compared with prescription-based approaches. However, no direct comparative analysis exists between in situ audiometry and self-adjustment strategies using self-fitting OTC (OTC-SF) hearing aids. Objective: To compare self-adjustment and in situ audiometry self-fitting strategies in OTC-SF hearing aids for adults with mild to moderate hearing difficulties. Design Settings and Participants: A crossover, within-participant pseudorandomized clinical trial was conducted between July and November 2023. Twenty-eight participants were pseudo-randomly assigned to 1 of the 2 self-fitting strategies, and they experienced both interventions for 4 consecutive weeks. Interventions: The self-adjustment group manually adjusted settings, including overall gain and spectral tilt, using Lexie B2 hearing aids, while the in situ audiometry group used Lexie B2 Plus hearing aids (Lexie Hearing by hearX Group), with an automated fitting based on in situ tests conducted through the app. Main Outcomes and Measures: The primary outcome was Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary outcomes were International Outcome Inventory for Hearing Aids (IOI-HA), speech-in-noise tests (DIN and QuickSIN), and real-ear measurements (REMs). Measures were completed at baseline and after the 4-week field trial using each strategy. Results: Twenty-eight participants (mean [SD] age, 60.2 [12.0] years) were included; 14 men and 14 women. Self-adjustment and in situ audiometry strategies produced no clinically meaningful differences across various outcome measures, including overall APHAB benefit (Cohen d = 0.2; 95% CI, -0.2 to 0.6) and overall IOI-HA satisfaction (Rosenthal r = 0.0; 95% CI, -0.3 to 0.2). Self-adjustment users reported higher satisfaction (Rosenthal r = -0.4; 95% CI, -0.6 to -0.1) and longer daily use (Rosenthal r = -0.3; 95% CI, -0.5 to 0.0) compared with those using in situ audiometry. No clinically meaningful differences were observed in speech-in-noise benefit and real-ear measurements. Conclusion and Relevance: In this clinical trial of OTC-SF hearing aids, self-adjustment and in situ audiometry strategies resulted in similar outcomes. However, self-adjustment may produce higher satisfaction and longer daily use, highlighting the potential advantages of active user involvement in the fitting process. Further investigation is needed for long-term outcomes. Trial registration: ClinicalTrials.gov Identifier: NCT05782153.

Molecular modelling and anticholinesterase activity of the essential oil from three chemotypes of Lippia alba (Mill.) N.E.Br. ex Britton & P. Wilson (Verbenaceae).

Lippia alba (Mill.) N.E. Brown (Verbenaceae), popularly known as "erva cidreira", is one of the most used plants in Brazilian folk medicine. The species has several chemotypes and its volatile constituents have already been characterized, and present different chemical markers with known pharmacological properties, such as analgesic, sedative and antifungal properties. The objective of this study was to evaluate the anticholinesterase activity (AChE) of the essential oil of three chemotypes of Lippia alba and, by using molecular anchoring, determine the best receptor-ligand interaction energies of the main constituents present in the samples of oil. The essential oils were obtained via hydrodistillation (LA1 and LA2) and steam drag (LA3), and their volatile constituents determined using GC-MS. For the determination of anticholinesterase activity, direct bioautography and colorimetry assays based on Ellman's method were used. Molecular docking was performed using a multiple solution genetic algorithm and Merck molecular force field 94 (MMFF94) as the scoring function. In the main constituents of the oil samples, three chemotypes were identified for L. alba: LA1 is rich in citral, LA2 is rich in carvone and LA3 is rich in linalool. All L. alba chemotypes showed AChE enzyme inhibition with an IC50 of 3.57 µg/mL (LA1), 0.1 µg/mL (LA2) and 4.34 µg/mL (LA3). The molecular docking study complemented the results of the experiment and demonstrated significant interactions between the main constituents of the oils and the amino acid residues of the AChE enzyme. Irrespective of the chemotype, Lippia alba presents biotechnological potential for the discovery of anticholinesterase substances, with the chemotype LA2 (rich in carvone) being the most active.

Smartphone-Facilitated In-Situ Hearing Aid Audiometry for Community-Based Hearing Testing.

OBJECTIVES: Hearing loss prevalence is increasing, with an estimated 2.5 billion people affected globally by 2050. Scalable service delivery models using innovative technologies and task-shifting are World Health Organization priorities to improve access to hearing care, particularly in low- and middle-income countries. Smartphone-facilitated audiometry in the community using hearing aids covered by noise-attenuating ear cups ("in-situ") could support more accessible hearing care when provided by less trained individuals such as community health workers (CHWs). This study aimed to determine the validity of this method for potential hearing aid fitting. Study objectives included determining the maximum permissible ambient noise level (MPANL), inter-device reliability, clinical threshold accuracy, reliability, and performance in real-world settings. DESIGN: Experiment 1: 15 normal-hearing adult participants were evaluated to determine MPANLs for circumaural Peltor 3M earcups covering Lexie Lumen hearing aids with smartphone-facilitated in-situ audiometry. MPANLs were calculated by measuring the difference in attenuation between thresholds obtained with standard headphones and in-situ hearing aids. Experiment 2: Pure-tone frequency and intensity output of 14 same-model Lexie Lumen hearing aids were measured to determine inter-device reliability. Pure-tone stimuli were measured and analyzed to determine sound pressure levels in decibels and pure-tone frequency when connected to a test box 2cc coupler. Experiment 3: 85 adult participants were tested in a sound booth to determine the accuracy of automated in-situ pure-tone audiometry (PTA) compared to clinical PTA (500, 1000, 2000, 3000, 4000, 6000 Hz) facilitated by an audiologist. The first 39 participants were tested twice to determine test-retest reliability. Experiment 4: In a community setting, 144 adult participants were tested with automated in-situ audiometry facilitated by CHWs using a smartphone app. These participants were subsequently tested with automated mobile PTA (500, 1000, 2000, 4000 Hz). An additional 44 participants were tested twice to determine test-retest reliability. RESULTS: Experiment 1: MPANLs of the Peltor 3M earcup-covered hearing aids were higher than standard headphones across all frequencies, ranging from 24 to 47.3 dB SPL. Experiment 2: Inter-device performance reliability was high, with all inter-device differences across all intensities and frequencies less than 3 dB. Frequency output was consistent and differed less than 0.7% between devices. Experiments 3 and 4: 85.2% and 83.3% of automated in-situ audiometry thresholds were within 10 dB of thresholds obtained in the sound booth and in a community setting, respectively. Acceptable test-retest intraclass correlation coefficient (ICC) was evident across all thresholds obtained in a sound booth (ICC = 0.85 to 0.93) and in a community setting (ICC = 0.83 to 0.97). CONCLUSIONS: Smartphone-facilitated in-situ audiometry allows for reliable and valid community-based testing. A simple smartphone user interface and automated in-situ audiometry allow CHWs with minimal training to facilitate the testing. With the additional capability to program hearing aids via the smartphone after the initial test, this approach would have the potential to support widespread access to personalized hearing aid fittings facilitated by CHWs in low- and middle-income countries. This approach also supports self-fitting options based on in-situ thresholds, enabling testing and fitting via over the counter hearing aids.

Nutritional status, feeding behavior, and oral conditions in preschool children exposed to secondhand smoke.

This study evaluated whether the nutritional status of preschoolers is influenced by secondhand smoke. Pairs of mothers-children (N = 201) were allocated in "children exposed to secondhand smoke (ESHS)" or "not exposed (N_ESHS)." Mothers answered, "The Parental Feeding Style Questionnaire (PFSQ)." The nutritional status and oral conditions were evaluated using WHO criteria. ESHS was 3.5 more likely to have a high BMI and their mothers had 10 kg more than N_ESHS. The probability of having dental caries was 2.28 and 3.68 times greater when the mother's BMI increases and when family/mothers were smokers, independently whether they smoke in the child's presence.

Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial.

Importance: Hearing loss is a highly prevalent condition, with numerous debilitating consequences when left untreated. However, less than 20% of US adults with hearing loss use hearing aids. Over-the-counter (OTC) hearing aids became available in October 2022 to improve access and affordability. However, clinical effectiveness studies of available OTC hearing aids using the existing devices in the market are limited. Objective: To compare the clinical effectiveness of a self-fitting OTC hearing aid with remote support and a hearing aid fitted using audiologist-fitted best practices. Design, Setting, and Participants: This randomized clinical effectiveness trial was conducted between April 14 and August 29, 2022. Sixty-eight adults with self-perceived mild to moderate hearing loss were recruited and randomly assigned to either the self-fitting or the audiologist-fitted group. Following bilateral hearing aid fitting, participants first completed a 2-week, take-home field trial without any support. Access to fine-tuning for both groups was only available after the 2-week trial. Support and adjustment were provided remotely for the self-fitting group per request and by the audiologist for the audiologist-fitted group. Participants were then reassessed after an additional 4-week take-home trial. Interventions: A commercially available self-fitting OTC hearing aid was provided to participants in the self-fitting group who were expected to set up the hearing aids using the commercially supplied instructional material and accompanying smartphone application. In the audiologist-fitted group, audiologists fitted the same hearing aid according to the National Acoustics Laboratories nonlinear version 2 algorithm for prescriptive gain target using real-ear verification with hearing aid use instruction. Main Outcomes and Measures: The primary outcome measure was self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. All measures were completed at baseline and at 2 intervals following hearing aid fitting (2 and 6 weeks). Results: Sixty-four participants were included in the analytic sample (33 men [51.6%]; mean [SD] age, 63.6 [14.1] years), with equal numbers of participants (n = 32) randomized into each group. The groups did not differ significantly in age (effect size r = -0.2 [95% CI, -0.3 to 0.2]) or 4-frequency pure-tone average (effect size r = 0.2 [95% CI, -0.1 to 0.4]). After the 2-week field trial, the self-fitting group had an initial advantage compared with the audiologist-fitted group on the self-reported APHAB (Cohen d = -0.5 [95% CI, -1.0 to 0]) and IOI-HA (effect size r = 0.3 [95% CI, 0.0-0.5]) but not speech recognition in noise. At the end of the 6-week trial, no meaningful differences were evident between the groups on any outcome measures. Conclusion and relevance: In this randomized clinical effectiveness trial, self-fitting OTC hearing aids with remote support yielded outcomes at 6 weeks post fitting comparable to those of hearing aids fitted using audiologist best practices. These findings suggest that self-fitting OTC hearing aids may provide an effective intervention for mild to moderate hearing loss. Trial Registration: ClinicalTrials.gov Identifier: NCT05337748.

Hearing Healthcare Professionals' Views about Over-The-Counter (OTC) Hearing Aids: Analysis of Retrospective Survey Data.

Over-the-counter hearing aids have been available to consumers in the US since 17 October 2022 following a ruling by the Food and Drug Administration. However, their reception by hearing healthcare professionals (HHP) has been mixed, and concerns have been expressed by many HHPs. The aim of this study was to examine the concerns that HHPs have towards over-the-counter (OTC) hearing aids. The study used a retrospective survey design. The survey data of HHPs (n = 730) was obtained from Hearing Tracker. A 22-item structured questionnaire was administered using a Question Scout platform. Descriptive analyses examined reported areas of concern and a Fisher's exact test examined the relationship between demographics and responses. A cluster analysis with partitioning around medoids (PAM) was used to identify a sub-group of participants based on responses. Nearly half of HHPs who participated reported that they will support patients with OTC hearing aids purchased elsewhere, whereas a quarter reported that they will sell OTC hearing aids in their clinic or website. HHPs expressed over 70% agreement in 'concern' statements in 14 of the 17 items. Issues about safety, counseling, and audiological care were the key concerns expressed by HHPs about OTC hearing aids. Some demographics (i.e., profession, primary position) were associated with responses to some statements. Two groups were identified based on the responses to concern statements. The HHPs in the first cluster 'OTC averse' (51%) agreed on all the 17 concern statements, whereas the second cluster 'OTC apprehensive' (49%) had some items rated as disagree (i.e., consumers will give up on amplification) and neither agree nor disagree (i.e., do not provide good value, warranties and return periods will be worse), and remaining items were rated as agree. OTC hearing aids were initiated to improve affordability, accessibility, and hearing aid uptake and are currently a rapidly emerging category of hearing devices. Overall, the results of the current study indicate that HHPs have serious concerns about OTC hearing aids. HHP concerns cited in this study provide useful feedback to stakeholders (e.g., HHP professional agencies, FDA, industry, and insurance payers) involved in improving OTC hearing aid implementation.

Satisfaction with hearing assessment feedback using the My Hearing Explained tool: client and audiologist perceptions.

OBJECTIVE: To determine the perceived satisfaction and understanding of hearing assessment feedback, using the Ida My Hearing Explained Tool (IMHET), compared to the standard audiogram reported by adult clients and audiologists. DESIGN: This study is a mixed-method design comparing clients and audiologists' perceptions through a single-blinded, randomised control trial and focus group discussions. After using either the audiogram or IMHET for feedback, clients and audiologists completed the adapted Patient Satisfaction Questionnaire (PSQ). STUDY SAMPLE: During client's initial audiological consultations, audiologists provided hearing assessment feedback (Total = 51) using the IMHET or audiogram. Twenty-seven clients and seven audiologists participated in focus groups, and/or open-ended questions. RESULTS: Satisfaction was not significantly different (p > 0.05) between the IMHET (76.18; SD: 2.66) or audiogram (75.63; SD: 4.73) for the overall PSQ scores reported by clients and audiologists. Two shared main themes, understanding and satisfaction, were identified for both tools from the focus groups and open-ended questions. A third main theme, recommendations, was identified only for the IMHET. CONCLUSIONS: The IMHET is a valuable resource for clients during hearing assessment feedback. Audiologists recommend that the audiogram be used as a supplement when using the IMHET to provide feedback.

Isolation and characterization of extracellular vesicles and future directions in diagnosis and therapy.

Extracellular vesicles (EVs) are a unique and heterogeneous class of lipid bilayer nanoparticles secreted by most cells. EVs are regarded as important mediators of intercellular communication in both prokaryotic and eukaryotic cells due to their ability to transfer proteins, lipids and nucleic acids to recipient cells. In addition to their physiological role, EVs are recognized as modulators in pathological processes such as cancer, infectious diseases, and neurodegenerative disorders, providing new potential targets for diagnosis and therapeutic intervention. For a complete understanding of EVs as a universal cellular biological system and its translational applications, optimal techniques for their isolation and characterization are required. Here, we review recent progress in those techniques, from isolation methods to characterization techniques. With interest in therapeutic applications of EVs growing, we address fundamental points of EV-related cell biology, such as cellular uptake mechanisms and their biodistribution in tissues as well as challenges to their application as drug carriers or biomarkers for less invasive diagnosis or as immunogens. This article is categorized under: Diagnostic Tools > Biosensing Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease Therapeutic Approaches and Drug Discovery > Nanomedicine for Infectious Disease.

Global use and outcomes of the hearWHO mHealth hearing test.

Objectives: The objective of this study was to examine the uptake, user characteristics, and performance of the free WHO smartphone hearing screening test (hearWHO) as a global hearing health promotion initiative. Method: We retrospectively examined the data of 242 626 tests conducted by adults (> 18 years) on the hearWHO app between February 2019 and May 2021. Test uptake was evaluated by country, WHO world region, test date, and demographics of age and gender. Results: The hearWHO test was completed in nearly every country globally (n = 179/195), with the greatest uptake seen in China and India. Uptake was greatest in the Western Pacific (32.9%) and European (24.8%) WHO regions. There was a high uptake of tests (44%) by young adults under the age of 30 years. Referral rates were typically higher for older age groups in most WHO regions, except for the African and Eastern Mediterranean regions, where overall hearWHO test uptake was lowest. Most testing (49%) took place in March (2019-2021) coinciding with World Hearing Day (3rd of March) each year. Conclusions: Digital mhealth tools provide many benefits in healthcare, including health promotion, access to information, and services for hearing loss. The hearWHO test was mainly reaching younger adults, positioning it as an important measure for public health advocacy to prevent hearing loss. Since hearing loss is primarily age related, more targeted campaigns or community-based initiatives should be directed toward older adults.

Remote Monitoring of Adult Cochlear Implant Recipients Using Digits-in-Noise Self-Testing.

PURPOSE: The COVID-19 pandemic has accelerated the uptake and scope of telehealth. This study determined the accuracy and reliability of a smartphone digits-in-noise (DIN) test when conducted by adult cochlear implant (CI) recipients in a simulated home environment compared with a clinic setup. Perceptions of remote monitoring using speech-in-noise (SIN) testing were also explored. METHOD: Thirty-three adult CI recipients between 18 and 78 years of age (M = 46.7, SD = ±20.4) conducted the DIN test in a simulated home environment and a clinic setup. Test-retest reliability across the two environments and comparisons between test settings were evaluated. A survey explored the perceptions of adult CI recipients regarding remote monitoring and use of the DIN self-test. RESULTS: Mean-aided speech reception thresholds (SRTs) in the clinic and simulated home environment test conditions and clinic and simulated home environment retest conditions did not differ significantly. Mean test-retest SRTs in the clinic and simulated home environment were significantly different (p < .05). High intraclass correlation coefficient and low standard error of measurement scores reflected good and excellent reliability between test-retest measures and between clinic and simulated home environment measures. Most participants were positive about the possibility of using the DIN test at home to self-assess speech perception, although some test adjustments such as including training items and a less adverse starting signal-to-noise ratio may be required. CONCLUSION: Adult CI recipients can use the smartphone DIN test to self-assess aided SIN performance in a home environment with accuracy and reliability relatively similar to clinic testing. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.20044418.

A Retrospective Analysis of Sacroiliac Joint Pain Interventions: Intraarticular Steroid Injection and Lateral Branch Radiofrequency Neurotomy.

BACKGROUND: Sacroiliac joint (SIJ) pain is a common etiology of chronic lower back pain. Treatment of persistent sacroiliac joint pain may entail intraarticular steroid injections and lateral branch radiofrequency neurotomy. OBJECTIVES: This study evaluates the efficacy of SIJ intervention treatments by comparing intraarticular steroid injections with lateral branch radiofrequency neurotomy. STUDY DESIGN: Retrospective cohort study. SETTING: We reviewed electronic medical records of patients with SIJ pain at Massachusetts General Hospital from 2006  through 2016 and identified 354 patients who received 930 SIJ intraarticular  injections and 19 patients who received 41 SIJ lateral branch radiofrequency neurotomies. METHODS: The Numeric Rating Scale (NRS) score for pain and the Eastern Cooperative Oncology Group (ECOG) Performance Status were measured prior to intervention and on follow-up. A mixed effects model was used to evaluate the duration of treatment effect. RESULTS: Patients who received an SIJ intraarticular steroid injection reported lower pain scores following treatment with a mean (standard deviation) NRS reduction from 6.77 (2.25) to 2.72 (2.81). SIJ lateral branch radiofrequency neurotomy resulted in NRS reduction from 5.96 (2.39) to 3.54 (3.14). A linear mixed model analysis suggests SIJ intraarticular steroid injections provided an estimated mean (CI 95%) of 38 (30-46.3) days of pain relief. Lateral branch radiofrequency neurotomy provided 82 (39.4-124.8) days of pain relief. The mean preprocedure ECOG score was 1.22 for both interventions and trended toward improvement with a post SIJ intraarticular injection score of 1.05 and SIJ lateral branch radiofrequency neurotomy score of 1.03. LIMITATIONS: There was variable follow-up reporting among patients. The small size of the lateral branch radiofrequency cohort limited intergroup comparisons. CONCLUSION: Both SIJ intraarticular steroid injections and SIJ lateral branch radiofrequency neurotomy demonstrated significant pain relief for patients with SIJ pain. SIJ lateral branch radiofrequency neurotomy provided a longer duration of pain relief (82 days) versus SIJ intraarticular steroid injection (38 days).

Improving the Efficiency of the Digits-in-Noise Hearing Screening Test: A Comparison Between Four Different Test Procedures.

PURPOSE: This study compared the test characteristics, test-retest reliability, and test efficiency of three novel digits-in-noise (DIN) test procedures to a conventional antiphasic 23-trial adaptive DIN (D23). METHOD: One hundred twenty participants with an average age of 42 years (SD = 19) were included. Participants were tested and retested with four different DIN procedures. Three new DIN procedures were compared to the reference D23 version: (a) a self-selected DIN (DSS) to allow participants to indicate a subjective speech recognition threshold (SRT), (b) a combination of self-selected and adaptive eight-trial DIN (DC8) that utilized a self-selected signal-to-noise ratio (SNR) followed by an eight-trial adaptive DIN procedure, and (c) a fixed SNR DIN (DF) approach using a fixed SNR value for all presentations to produce a pass/fail test result. RESULTS: Test-retest reliability of the D23 procedure was better than that of the DSS and DC8 procedures. SRTs from DSS and DC8 were significantly higher than SRTs from D23. DSS was not accurate to discriminate between normal-hearing and hard of hearing listeners. The DF and DC8 procedures with an adapted cutoff showed good hearing screening test characteristics. All three novel DIN procedure durations were significantly shorter (< 70 s) than that of D23. DF showed a reduction of 46% in the number of presentations compared to D23 (from 23 presentations to an average of 12.5). CONCLUSIONS: The DF and DC8 procedures had significantly lower test durations than the reference D23 and show potential to be more time-efficient screening tools to determine normal hearing or potential hearing loss. Further studies are needed to optimize the DC8 procedure. The reference D23 remains the most reliable and accurate DIN hearing screening test, but studies in which the potentially efficient new DIN procedures are compared to pure-tone thresholds are needed to validate these procedures.

Diotic and Antiphasic Digits-in-noise Testing as a Hearing Screening and Triage Tool to Classify Type of Hearing Loss.

OBJECTIVES: The digits-in-noise test (DIN) is a popular self-test measure that has traditionally been used to screen for hearing loss by providing either a pass or refer result. Standard approaches either tested each ear monaurally or used a binaural diotic version where identical digits and noise were presented simultaneously to both ears. Recently, a dichotic, antiphasic version was developed, increasing sensitivity of the DIN to unilateral or asymmetric sensorineural hearing loss (SNHL) and conductive hearing loss (CHL). The purpose of this study was to determine predictors and normative ranges of the antiphasic and diotic DIN and to determine if a combination of diotic and antiphasic DIN could accurately categorize hearing into (1) normal, (2) bilateral SNHL, or (3) unilateral SNHL or CHL. DESIGN: The analytical sample consisted of 489 participants between the ages of 18 and 92 years with varying types, symmetry, and degrees of hearing loss. Degree and type of hearing loss were determined based on standard clinical four-frequency (0.5-4 kHz) pure-tone air and bone conduction threshold averages. The sample consisted of bilateral normal hearing (n = 293), bilateral SNHL (n = 172), unilateral SNHL (n = 42), and CHL (n = 32). All participants (n = 489) first completed an antiphasic DIN (digit stimuli 180° out-of-phase between ears), while 393 of the sample also completed a diotic DIN. Two procedures were assessed for their ability to categorize hearing into one of the three hearing groups. The first used a fixed antiphasic cutoff combined with a cutoff formed by a linear combination of antiphasic and diotic speech recognition threshold (SRT) or binaural intelligibility-level difference. RESULTS: Poorer ear pure-tone average was the strongest predictor of antiphasic DIN score, whereas better ear pure-tone average explained more of the variance in diotic SRT. The antiphasic DIN sensitivity and specificity was 90% and 84%, respectively, for detecting hearing loss, with outstanding area under the receiver operating characteristics values exceeding 0.93 to identify hearing loss in the poorer ear. The first fixed SRT cutoff procedure could categorize 75% of all participants correctly, while the second procedure increased correct categorization to 79%. False negative rates for both procedures were below 10%. CONCLUSIONS: A sequential antiphasic and diotic DIN could categorize hearing to a reasonable degree into three groups of (1) normal hearing; (2) bilateral SNHL; and (3) unilateral asymmetric SNHL or CHL. This type of approach could optimize care pathways using remote and contactless testing, by identifying unilateral SNHL and CHL as cases requiring medical referral. In contrast, bilateral SNHL cases could be referred directly to an audiologist, or nontraditional models like OTC hearing aids.

Proteomic identification of the contents of small extracellular vesicles from in vivo Plasmodium yoelii infection.

Small extracellular vesicles, including exosomes, are formed by the endocytic pathway and contain genetic and protein material which reflect the contents of their cells of origin. These contents have a role in vesicle-mediated information transfer, as well as physiological and pathological functions. Thus, these vesicles are of great interest as therapeutic targets, or as vehicles for immunomodulatory control. In Plasmodium spp. infections, vesicles derived from the parasite or parasite-infected cells have been shown to induce the expression of pro-inflammatory elements, which have been correlated with manifestations of clinical disease. Herein, we characterised the protein cargo of naturally occurring sEVs in the plasma of P. yoelii-infected mice. After in vivo infections, extracellular vesicles in the size range of exosomes were collected by sequential centrifugation/ultracentrifugation followed by isopycnic gradient separation. Analysis of the vesicles was performed by transmission electron microscopy, dynamic light scattering, SDS-PAGE and flow cytometry. LC-MS analysis followed by bioinformatics analysis predicted parasite protein cargo associated with exosomes. Within these small extracellular vesicles, we identified proteins of interest as vaccine candidates, uncharacterized proteins which may be targets of T cell immunoreactivity, and proteins involved in metabolic processes, regulation, homeostasis and immunity. Importantly, the small extracellular vesicles studied in our work were obtained from in vivo infection rather than from the supernatant of in vitro cultures. These findings add to the growing interest in parasite small extracellular vesicles, further our understanding of the interactions between host and parasite, and identify novel proteins which may represent potential targets for vaccination against malaria.

French Version of the Antiphasic Digits-in-Noise Test for Smartphone Hearing Screening.

In France 58% of persons with hearing loss still do not wear hearing aids. Pure-tone audiometry is the traditional gold standard in assessment and screening of hearing impairment, but it requires the use of calibrated devices and soundproof booth. The antiphasic digits-in-noise (DIN) test does not require calibrated material and can run on a standard headset or earbuds connected to a smartphone or a computer. The DIN test is highly correlated with pure tone audiometry and has already shown to be effective in hearing loss screening in its English version promoted by the WHO. The aim of the present study was to develop and validate a French version of the antiphasic DIN test for implementation on a national screening test offered as a smartphone app. The audio files recorded from a French native female speaker were selected and normalized in intensity according to their recognition probability. The French DIN test application was then tested on normal hearing- and hearing-impaired subjects. Based on the strong correlation between pure tone audiometry (PTA) and DIN SRT, we calculated ROC curves and Z-score. For PTA > 20 dB HL, a SNR cutoff of 12.9 dB corresponds to a sensitivity and specificity of 0.96 and 0.93, respectively. To detect moderate and more severe hearing loss (PTA > 40 dB HL), the SNR cutoff was -10.9 dB, corresponding to a sensitivity and specificity of 0.99 and 0.83, respectively. The Z-score was calculated to define statistical criteria of normality for speech-in-noise evaluation. While a score of 0 roughly corresponds to the normality (DIN SRT = -15.4 dB SNR), a subject with DIN SRT > -12.2 (Z-score > 2) is ranked in the hearing loss population. Next, the French antiphasic DIN test was implemented in the Höra iOS and Android apps. In total, 19,545 Höra tests were completed and analyzed. Three quarters of them were classified as normal (74 %) and one quarter presented mild (9%) or more severe loss (17%). Together, results argue for the use of the French version of antiphasic DIN test in the general population to improve the screening of hearing-impaired individuals.

An analytical method to convert between speech recognition thresholds and percentage-correct scores for speech-in-noise tests.

Speech-in-noise tests use fixed signal-to-noise ratio (SNR) procedures to measure the percentage of correctly recognized speech items at a fixed SNR or use adaptive procedures to measure the SNR corresponding to 50% correct (i.e., the speech recognition threshold, SRT). A direct comparison of these measures is not possible yet. The aim of the present study was to demonstrate that these measures can be converted when the speech-in-noise test meets specific criteria. Formulae to convert between SRT and percentage-correct were derived from basic concepts that underlie standard speech recognition models. Information about the audiogram is not being used in the proposed method. The method was validated by comparing the direct conversion by these formulae with the conversion using the more elaborate Speech Intelligibility Index model and a representative set of 60 audiograms (r = 0.993 and r = 0.994, respectively). Finally, the method was experimentally validated with the Afrikaans sentence-in-noise test (r = 0.866). The proposed formulae can be used when the speech-in-noise test uses steady-state masking noise that matches the spectrum of the speech. Because pure tone thresholds are not required for these calculations, the method is widely applicable.

Facilitating discontinuation of intravenous opioids by -concurrent use of sublingual buprenorphine with rapid microdosing -induction: A pain management case study.

We report a case in which sublingual buprenorphine was used to help transition a patient off intravenous (IV) opioid analgesics medications post-multiple abdominal procedures. Intravenous opioids are commonly used in inpatient surgical pain management for patients with severe pain who are unable to take oral medications. Typically, a short course of IV analgesics is used, followed by transition to oral analgesic regimen. However, in patients with poor gastrointestinal absorption, pain control can be challenging. We present this case to highlight how sublingual buprenorphine can be a useful agent for acute pain management, especially when conventional strategies provide suboptimal responses.

Speech Recognition in Noise Using Binaural Diotic and Antiphasic Digits-in-Noise in Children: Maturation and Self-Test Validity.

BACKGROUND: Digits-in-noise (DIN) tests have become popular for hearing screening over the past 15 years. Several recent studies have highlighted the potential utility of DIN as a school-aged hearing test. However, age may influence test performance in children due to maturation. In addition, a new antiphasic stimulus paradigm has been introduced, allowing binaural intelligibility level difference (BILD) to be measured by using a combination of conventional diotic and antiphasic DIN. PURPOSE: This study determined age-specific normative data for diotic and antiphasic DIN, and a derived measure, BILD, in children. A secondary aim evaluated the validity of DIN as a smartphone self-test in a subgroup of young children. RESEARCH DESIGN: A cross-sectional, quantitative design was used. Participants with confirmed normal audiometric hearing were tested with a diotic and antiphasic DIN. During the test, arrangements of three spoken digits were presented in noise via headphones at varying signal-to-noise ratio (SNR). Researchers entered each three-digit spoken sequence repeated by the participant on a smartphone keypad. STUDY SAMPLE: Overall, 621 (428 male and 193 female) normal hearing children (bilateral pure tone threshold of ≤ 20 dB hearing level at 1, 2, and 4 kHz) ranging between the ages of 6 and 13 years were recruited. A subgroup of 7-year-olds (n = 30), complying with the same selection criteria, was selected to determine the validity of self-testing. DATA COLLECTION AND ANALYSIS: DIN testing was completed via headphones coupled to a smartphone. Diotic and antiphasic DIN speech recognition thresholds (SRTs) were analyzed and compared for each age group. BILD was calculated through subtraction of antiphasic from diotic SRTs. Multiple linear regressions were run to determine the effect of age on SRT and BILD. In addition, piecewise linear regressions were fit across different age groups. Wilcoxon signed-rank tests were used to determine differences between self- and facilitated tests. RESULTS: Age was a significant predictor, of both diotic and antiphasic DIN SRTs (p < 0.05). SRTs improved by 0.15 dB and 0.35 dB SNR per year for diotic and antiphasic SRTs, respectively. However, age effects were only significant up to 10 and 12 years for antiphasic and diotic SRTs, respectively. Age significantly (p < 0.001) predicted BILD, which increased by 0.18 dB per year. A small SRT advantage for facilitated over self-testing was seen but was not significant (p > 0.05). CONCLUSIONS: Increasing age was significantly associated with improved SRT and BILD using diotic and antiphasic DINs. DIN could be used as a smartphone self-test in young children from 7 years of age with appropriate quality control measures to avoid potential false positives.

Memory CD8+ T cell compartment associated with delayed onset of Plasmodium falciparum infection and better parasite control in sickle-cell trait children.

OBJECTIVES: Study of individuals with protection from Plasmodium falciparum (Pf) infection and clinical malaria, including individuals affected by the sickle-cell trait (HbAS), offers the potential to identify cellular targets that could be translated for therapeutic development. We previously reported the first involvement of cellular immunity in HbAS-associated relative protection and identified a novel subset of memory-activated NK cells that was enriched in HbAS children and associated with parasite control. We hypothesised that other memory cell subsets might distinguish the baseline profile of HbAS children and children with normal haemoglobin (HbAA). METHODS: Subsets of memory T cells and NK cells were analysed by flow cytometry in paired samples collected from HbAS and HbAA children, at baseline and during the first malaria episode of the ensuing transmission season. Correlations between cell frequencies and features of HbAS-mediated protection from malaria were determined. RESULTS: HbAS children displayed significantly higher frequency of memory CD8+ T cells at baseline than HbAA children. Baseline frequency of memory CD8+ T cells correlated with features of HbAS-mediated protection from malaria. Exploration of memory CD8+ T cell subsets revealed that central memory CD8+ T cell frequency was higher in HbAS children than in HbAA children. CONCLUSION: This study shows that HbAS children develop a larger memory CD8+ T cell compartment than HbAA children, and associates this compartment with better control of subsequent onset of infection and parasite density. Our data suggest that central memory CD8+ T cells may play an important role in the relative protection against malaria experienced by HbAS individuals, and further work to investigate this is warranted.