Cochlear implantation in pediatrics: Impact of newborn hearing screening on intervention time.

OBJECTIVES: The newborn hearing screening (NHS) program was globally established for early hearing loss (HL) identification and intervention. Early intervention is essential to minimize or prevent the negative consequences of HL. In Saudi Arabia, the NHS was officially implemented in 2016. Currently, its impact on the timing of cochlear implantations (CIs) in Saudi Arabia remains unclear, and information on potential hospital-related delays affecting early implantation is lacking. Thus, this study aimed to evaluate the effect of implementing the NHS on age at CI in children with prelingual deafness in a CI center in Saudi Arabia, and to evaluate the hospital timing in the CI process. METHODS: All pediatric CI users who presented for the first time to the CI committee (CIC) at a tertiary center and received their implants between 2015 and 2022 were enrolled in this study. Date of birth (DOB), date of presentation to the CI committee (DOCIC), and date of CI surgery (DOCIS) were retrospectively reviewed. RESULTS: In total, 304 CI children were included in the analysis. Approximately 55 % of the children (n = 167) were screened for HL through the NHS, whereas 45 % of the children (n = 137) were born before the launch of the NHS. Both age at the presentation to the CIC (i.e. difference between DOCIC and DOB) and age at implantation (i.e. difference between DOCIS and DOB) were significantly earlier in children who were screened for HL through the NHS than those who were not screened (P < 0.0001). The time difference between the DOCIC and DOCIS was not significantly different between the screened and unscreened children (P > 0.05). CONCLUSION: The implementation of the NHS in the tertiary center has a significant positive effect on age at presentation to the CIC and age at implantation, but not on the actual CI surgery. Further research is needed to reduce the hospital delays before the actual surgery in order to increase the likelihood of children receiving implantation early in their life.

A novel method for evaluating mastoid defect regrowth after cochlear implantation.

This retrospective study examined mastoid defects resulting from cochlear implant (CI) surgery and their potential for spontaneous regrowth across different age groups. Spontaneous closure of mastoid defects has been observed in certain CI patients during revision surgery or through post-operative temporal bone computer tomography (TB-CT). The analysis encompassed 123 CI recipients, comprising 81.3% children and 18.7% adults, who underwent post-operative TB-CT scans. Using image adjustment software, the study measured mastoid defect areas and found a significant reduction in children's defects between the initial and subsequent scans. Notably, mastoid defect areas differed significantly between children and adults at both time points. Furthermore, the analysis revealed significant correlations between mastoid defect areas and the age at implantation as well as the time elapsed since the CI surgery and the first CT scan. This study provides valuable insights for evaluating CI patients scheduled for revision surgery by assessing potential surgical challenges and duration. Furthermore, it may have a pivotal role in evaluating patients who experience postauricular swelling subsequent to CI surgery.

A novel radiological software prototype for automatically detecting the inner ear and classifying normal from malformed anatomy.

BACKGROUND: To develop an effective radiological software prototype that could read Digital Imaging and Communications in Medicine (DICOM) files, crop the inner ear automatically based on head computed tomography (CT), and classify normal and inner ear malformation (IEM). METHODS: A retrospective analysis was conducted on 2053 patients from 3 hospitals. We extracted 1200 inner ear CTs for importing, cropping, and training, testing, and validating an artificial intelligence (AI) model. Automated cropping algorithms based on CTs were developed to precisely isolate the inner ear volume. Additionally, a simple graphical user interface (GUI) was implemented for user interaction. Using cropped CTs as input, a deep learning convolutional neural network (DL CNN) with 5-fold cross-validation was used to classify inner ear anatomy as normal or abnormal. Five specific IEM types (cochlear hypoplasia, ossification, incomplete partition types I and III, and common cavity) were included, with data equally distributed between classes. Both the cropping tool and the AI model were extensively validated. RESULTS: The newly developed DICOM viewer/software successfully achieved its objectives: reading CT files, automatically cropping inner ear volumes, and classifying them as normal or malformed. The cropping tool demonstrated an average accuracy of 92.25%. The DL CNN model achieved an area under the curve (AUC) of 0.86 (95% confidence interval: 0.81-0.91). Performance metrics for the AI model were: accuracy (0.812), precision (0.791), recall (0.8), and F1-score (0.766). CONCLUSION: This study successfully developed and validated a fully automated workflow for classifying normal versus abnormal inner ear anatomy using a combination of advanced image processing and deep learning techniques. The tool exhibited good diagnostic accuracy, suggesting its potential application in risk stratification. However, it is crucial to emphasize the need for supervision by qualified medical professionals when utilizing this tool for clinical decision-making.

Cochlear Implant Single-Unit Audio Processors in Young Children.

BACKGROUND: RONDO 2 is a lightweight, compact, wirelessly charged, and fully integrated single-unit speech processor. Single-unit processors provide an effective and convenient alternative to behind-the-ear processors for adults. Therefore, the aim of this study was to investigate if RONDO 2 is suitable for and did not compromise the hearing performance of young children in everyday life. METHODS: Thirteen children aged -lt;4 years were fitted with the RONDO 2 speech processor at the first activation of the cochlear implant. They were evaluated with the LittlEARS® Auditory Questionnaire, LittlEARS® Early Speech Production Questionnaire, and the Speech, Spatial, and Qualities of Hearing Scale 12 pre-implantation. In addition to these measures, they were evaluated with the Audio Processor Satisfaction Questionnaire post-implantation. Duration of daily use and troubleshooting data were acquired. Evaluation occurred at 4 time points: before implantation and 1, 3, and 12 months post-initial activation. RESULTS: Ten out of 13 children continued using RONDO 2 after the study. Twelve months after implantation, they used it on average 11.6 hours per day and had an average Audio Processor Satisfaction Questionnaire score of 9.1 out of 10. Average hearing performance scores continuously improved throughout the follow-up period across measures. Twelve months after implantation, the mean scores were 30.1 out of 35 for the LittlEARS® Auditory Questionnaire, 19.9 out of 27 for the LittlEARS® Early Speech Production Questionnaire, and 7.4 out of 10 for the Speech, Spatial, and Qualities of Hearing Scale 12. CONCLUSION: Participants demonstrated high levels of satisfaction and good hearing performance with RONDO 2, which indicates that this single-unit processor could be a viable and comfortable alternative to behind-the-ear processors in young children, although larger controlled experiments are warranted.

Enhancing cochlear duct length estimation by incorporating second-turn parameters.

Estimating insertion depth, cochlear duct length (CDL), and other inner ear parameters is vital to optimizing cochlear implantation outcomes. Most current formulas use only the basal turn dimensions for CDL prediction. In this study, we investigated the importance of the second turn parameters in estimating CDL. Two experienced neuro-otologists blindly used segmentation software to measure (in mm) cochlear parameters, including basal turn diameter (A), basal turn width (B), second-turn diameter (A2), second-turn width (B2), CDL, first-turn length, and second-turn length (STL). These readings were taken from 33 computed tomography (CT) images of temporal bones from anatomically normal ears. We constructed regression models using A, B, A2, and B2 values fitted to CDL, two-turn length, and five-fold cross-validation to ensure model validity. CDL, A value, and STL were longer in males than in females. The mean B2/A2 ratio was 0.91 ± 0.06. Adding A2 and B2 values improved CDL prediction accuracy to 86.11%. Therefore, we propose a new formula for more accurate CDL estimation using A, B, A2, and B2 values. In conclusion, the findings of this study revealed a notable improvement in the prediction of two-turn length (2TL), and CDL by clinically appreciable margins upon adding A2 and B2 values to the prediction formulas.

A Literature Review on Cochlear Implant Activation: From Weeks to Hours.

Objectives: The present literature review discusses the chronological evolution of Cochlear Implant (CI) activation and its definition among the relevant studies in the literature. In addition, the benefits of standardizing the early activation process in implantation centers worldwide are discussed. Methods: A comprehensive literature search was conducted in the major databases such as PubMed, Scopus, and Embase to retrieve all the relevant articles that reported early activation approaches following CI. Results: The evolution of the timing of early activation after CI has been remarkable in the past few years. Some studies reported the feasibility of early activation 1 day after the CI surgery in their users. Conclusions: Within the last decade, some studies have been published to report the feasibility and outcomes of its early activation. However, the process of early activation was not adequately defined, and no apparent guidelines could be found in the literature.

Early activation after cochlear implantation: a systematic review.

PURPOSE: To systematically review the outcomes of early activation following cochlear implantation (CI) based on the findings from different studies in the literature. METHODS: A comprehensive search strategy was conducted through different databases to identify relevant articles. Our outcomes included impedance levels, rates of complications, hearing and speech perception performance, and patients' satisfaction levels. RESULTS: The total number of included studies in this systematic review is 19, which recruited 1157 patients, including 857 who underwent early activation following CI. Seventeen studies investigated impedance levels or feasibility rates of early activation approaches. Most of these studies (n = 10) reported that mean impedance levels remarkably decreased within the first day-to-month (first measurement) post-activation. In addition, all 17 studies showed that impedance levels finally normalize and become comparable with intraoperative levels or the conventional activation group. Seventeen studies reported the occurrence of complications in their population. Ten of these studies indicated that none of their patients developed any post-operative complications after early activation. Seven studies reported the development of some minor complications, including pain 9.2% (28/304), infection 4.7% (13/275), swelling 8.2% (25/304), vertigo 15.1% (8/53), skin hyperemia 2.2% (5/228), and others 16.4% (9/55). Hearing and speech perception was assessed in six studies, which showed a remarkable improvement in their patients. Three studies investigated patients' satisfaction and showed high satisfaction levels. Only one report investigated the economic advantages of early activation. CONCLUSION: Early activation is safe and feasible and does not impact the hearing and speech outcomes of the patients undergoing CI procedures.

Cochlear Implantation in Pediatrics: The Effect of Cochlear Coverage.

The effect of insertion depth and position of cochlear implant (CI) electrode arrays on speech perception remains unclear. This study aimed to determine the relationship between cochlear coverage and speech performance in children with prelingual hearing loss with CI. Pure tone audiometry (PTA) and speech audiometry, including speech reception threshold (SRT) using spondee words and speech discrimination score (SDS) using phonetically balanced monosyllabic words, were tested. The Categories of Auditory Performance (CAP) and Speech Intelligibility Rating (SIR) scales were also used. Thirty-one ears were implanted with the FLEX 28 electrode array, and 54 with the FORM 24 were included in the current study. For the studied ear, the mean cochlear duct length was 30.82 ± 2.24 mm; the mean cochlear coverage was 82.78 ± 7.49%. Cochlear coverage was a significant negative predictor for the mean pure tone threshold across frequecnies of 0.5, 1, 2, and 4 kHz (PTA4) (p = 0.019). Cochlear coverage was a significant positive predictor of SDS (p = 0.009). In children with cochlear coverage ≥ 82.78%, SDS was significantly better than in those with coverage < 82.78% (p = 0.04). Cochlear coverage was not a significant predictor of the SRT, CAP, or SIR. In conclusion, the cochlear coverage of the CI electrode array has an impact on the users' SDS. Further long-term studies with larger sample sizes should be conducted to address the most critical factors affecting CI recipients' outcomes.

Cochlear Implantation: The Volumetric Measurement of Vestibular Aqueduct and Gusher Prediction.

This study aimed to validate the role of 3D segmentation in measuring the volume of the vestibular aqueduct (VAD), and the inner ear, and to study the correlation between VAD volume and VAD linear measurements at the midpoint and operculum. The correlation with other cochlear metrics was also studied. We retrospectively recruited 21 children (42 ears) diagnosed with Mondini dysplasia (MD) plus enlarged vestibular aqueduct (EVA) from 2009 to 2021 and who underwent cochlear implantation (CI). Patients' sociodemographic data were collected, and linear cochlear metrics were measured using Otoplan. Vestibular aqueduct width and vestibular aqueduct and inner ear volumes were measured by two independent neuro-otologists using 3D segmentation software (version 4.11.20210226) and high-resolution CT. We also conducted a regression analysis to determine the association between these variables and CT VAD and inner ear volumes. Among the 33 cochlear implanted ears, 13 ears had a gusher (39.4%). Regarding CT inner ear volume, we found that gender, age, A-value, and VAD at the operculum were statistically significant (p-Value = 0.003, <0.001, 0.031, and 0.027, respectively) by regression analysis. Moreover, we found that Age, H value, VAD at the midpoint, and VAD at the operculum were significant predictors of CT VAD volume (p-Value < 0.04). Finally, gender (OR: 0.092; 95%CI: 0.009-0.982; p-Value = 0.048) and VAD at the midpoint (OR: 0.106; 95%CI: 0.015-0.735; p-Value = 0.023) were significant predictors of gusher risk. Patients' gusher risk was significantly differentiated by gender and VAD width at the midpoint.

Cochlear Implantation: The use of OTOPLAN Reconstructed Images in Trajectory Identification.

OBJECTIVES: This study aimed to define the best electrode trajectory line in cochlear implant (CI) surgery using the OTOPLAN (otology planning software) reconstructed 3D model and to investigate the surgical distance of the retro-facial approach as a direct access to the round window. METHODS: Computed tomography (CT) scans of the normal temporal bone were included for analysis in this study. OTOPLAN reconstruction was used to build 3D models with specific ear structures for study analysis. RESULTS: Twenty-five scans were included; the average age at the time of CT scan was 6.8±12 years. Twelve scans (48%) were right-sided and thirteen (52%) were left-sided. The best trajectory line to the round window was identified in all scans. The retro-facial approach was the optimal approach for 52% of cases (13/25). In all scans, the safe distance from the facial nerve were in favor of the retro-facial approach (P = 0.0011). CONCLUSION: The OTOPLAN reconstructed imaging provided a good analysis of the retro-facial approach and helped in planning the surgical trajectory line towards the round window. Additionally, calculation of the surgical distance can help the surgeon compare the retro-facial approach to the standard facial recess for preoperative planning. These findings may help in robotic surgery.

Method to estimate the basal turn length in inner ear malformation types.

The mathematical equations to estimate cochlear duct length (CDL) using cochlear parameters such as basal turn diameter (A-value) and width (B-value) are currently applied for cochleae with two and a half turns of normal development. Most of the inner ear malformation (IEM) types have either less than two and a half cochlear turns or have a cystic apex, making the current available CDL equations unsuitable for cochleae with abnormal anatomies. Therefore, this study aimed to estimate the basal turn length (BTL) from the cochlear parameters of different anatomical types, including normal anatomy; enlarged vestibular aqueduct; incomplete partition types I, II, and III; and cochlear hypoplasia. The lateral wall was manually tracked for 360° of the angular depth, along with the A and B values in the oblique coronal view for all anatomical types. A strong positive linear correlation was observed between BTL and the A- (r2 = 0.74) and B-values (r2 = 0.84). The multiple linear regression model to predict the BTL from the A-and B-values resulted in the following equation (estimated BTL = [A × 1.04] + [B × 1.89] - 0.92). The manually measured and estimated BTL differed by 1.12%. The proposed equation could be beneficial in adequately selecting an electrode that covers the basal turn in deformed cochleae.

A Machine Learning Model to Predict Citation Counts of Scientific Papers in Otology Field.

One of the most widely used measures of scientific impact is the number of citations. However, due to its heavy-tailed distribution, citations are fundamentally difficult to predict but can be improved. This study was aimed at investigating the factors and parts influencing the citation number of a scientific paper in the otology field. Therefore, this work proposes a new solution that utilizes machine learning and natural language processing to process English text and provides a paper citation as the predicted results. Different algorithms are implemented in this solution, such as linear regression, boosted decision tree, decision forest, and neural networks. The application of neural network regression revealed that papers' abstracts have more influence on the citation numbers of otological articles. This new solution has been developed in visual programming using Microsoft Azure machine learning at the back end and Programming Without Coding Technology at the front end. We recommend using machine learning models to improve the abstracts of research articles to get more citations.

Mastoid Growth and the Configuration of Cochlear Implant Electrode Lead.

OBJECTIVES: To study the changes in the coiled configuration of electrode excess lead in the mastoid cavity in the cochlear implant recipients over time. METHODS: Post-operative CT scans at two different appointments of fourteen patients with cochlear implants (CI) were retrospectively analyzed using a DICOM viewer software (3D-slicer). Mastoid thickness (MT) was measured in the oblique coronal plane from the round window (RW) entrance to the mastoid edge and inter-cochlear distance (ICD) was measured in the axial plane at the fundus level between two ears. 3D segmentation of the entire inner ear of both sides and coiled electrode excess lead was performed to visually compare the changes in coiled configuration between the two CT scan time points. RESULT: MT and ICD increased logarithmically with the patient's age, as has been measured from both the 1st and the 2nd CT scans and a weak linear correlation between MT and ICD was observed. Growth in MT and ICT measured between the time of 1st and 2nd CT scans showed a strong linear correlation. In eight cases, changes in the electrode excess lead have been observed in the 2nd CT scan, either a change in the coiling configuration of electrode excess lead or shifted laterally toward the mastoid edge. The ICD growth between the 1st and the 2nd CT scans was >2 mm in only seven cases and all of them were children. All other six cases had no observed changes in the coiled electrode lead. In addition, the mastoid growth between the 1st and the 2nd CT scan was >2.5 mm in only 4 cases. CONCLUSION: Coiled configuration of electrode excess lead could change when the MT and ICD increased over time.

Pregnancy-Related Giant Nasal Mass: A Diagnostic Dilemma.

SIGNIFICANCE STATEMENT: Pregnancy-related giant nasal masses often present a diagnostic challenge and clinical dilemma due to the obvious restrictions in utilizing imaging and general anesthesia during pregnancy. Therefore, we highlight the importance of clinical judgment, especially during pregnancy, and should not disregard certain clinical cues. In addition, we recommend an in-office polypectomy for giant nasal polyps worsening during pregnancy and nasal steroids to optimize their quality of life while avoiding systemic medications or further interventions.

Changes in the Area Adjacent to the Internal Receiver-Stimulator of Cochlear Implant: A Retrospective Study.

BACKGROUND: In some patients with cochlear implants, bony resorption at the internal receiver- stimulator site can be observed on postoperative computed tomography. Therefore, it is essential to elucidate the effects of the internal receiver-stimulator on the scalp and bony bed over time. OBJECTIVE: We aimed to evaluate how the internal receiver-stimulator of a cochlear implant device changed the thickness of the surrounding scalp and skull over time using computed tomography. METHODS: This retrospective study evaluated patients who underwent cochlear implantation and received two computed tomography scans postoperatively for different indications at a tertiary referral centre. The main outcomes were scalp thickness and bony bed depth. RESULTS: Fourteen ears were included in this study. There was very good inter-rater reliability among the two readers who evaluated the computed tomography of the included patients, with a Cronbach's alpha of 0.94. The mean scalp thickness over the internal receiver-stimulator was 6.02 (+/-2.4) mm in the first scan and decreased with no significant change to 5.62 mm (+/-1.64) in the second scan (p = 0.59, paired t-test). The mean depth of the bony bed increased significantly from 1.39 mm (+/-0.93) to 2.62 mm (+/-1.24) (p = 0.03). CONCLUSION: There was no change in the thickness of the scalp overlying the internal receiver-stimulator indicating that the scalp was more resistant than the bony skull to the tensile pressure exerted by the internal receiver-stimulator. In contrast, the bony bed depth of the internal receiver-stimulator increased over time. This can result in decreased internal receiver-stimulator protrusion and decreased risk of device displacement and migration.

Caregivers' Willingness to Vaccinate Their Children Against COVID-19 in Saudi Arabia: A Cross-Sectional Survey.

Background In early 2021, vaccination against COVID-19 became one of the most important measures needed to control the pandemic. Objectives This study aimed to investigate the levels of acceptance and factors affecting the decisions among Saudi parents and caregivers of children under 12 for getting them vaccinated. Design and setting A cross-sectional survey of 1000 caregivers and parents was carried out from May 2021 to June 2021. The participants were from the eastern, central, southern, western, and northern provinces of Saudi Arabia. Materials and methods The data were collected and managed using Microsoft Excel (Microsoft® Corp., Redmond, WA) and analyzed using SPSS version 23 (IBM Corp., Armonk, NY). Results Of the 1000 respondents, 281 (28.1%) reported they would vaccinate their children, 346 (34.6%) rejected vaccination, and 373 (37.3%) were not sure. Most caregivers (24.1%; n = 241) reported protecting children as the principal reason for accepting vaccination. Regarding those rejecting the vaccine, the most common concern was that children might experience side effects (42.9%; n = 429). Limitations The acceptance of the COVID-19 vaccine is dynamic and changes with legislations and public awareness policies. Conclusions COVID-19 vaccine acceptance for children was low at the time of this study compared to the United Kingdom and United States. To achieve vaccination coverage that is adequate for herd immunity in Saudi Arabia, intense educational and awareness strategies are needed.

Cochlear implant: More hearing better speech performance.

BACKGROUND: Datalogging feature of the cochlear implant audio processor has been utilized to calculate the average daily wearing hours for cochlear implant devices by patients. OBJECTIVES: To assess the relationship between the time use of cochlear implant audio processor and speech development as well as to identify the lowest acceptable duration of audio processor use to achieve an acceptable language development. METHODS: A retrospective study design including prelingual thirty-four ears (24 patients) who received the same electrode array of cochlear implant with 2 years follow up. The audiological and speech evaluations were done for all patients postoperatively and the last postoperative follow-up visit was used for analysis in this study. RESULTS: The average daily use of the audio processor was 11.3 ± 2.7 h per day. The pure tone average was 30.55 ± 4.64 dB whereas the speech reception threshold was 30.88 ± 6.12 dB. The average speech discrimination score at 65 dB was 68.59 ± 16.80%. A significant positive correlation (r = 0.54, p value = 0.0009) was found between the daily use of the audio processor and the speech discrimination score. The lowest wearing time needed to have more than 60% of the speech discrimination score was 8.3 h/day. CONCLUSION: The present study revealed a positive correlation between the daily duration of the audio processor usage and speech performance. Moreover, we found that pediatric patients need to use their cochlear implant device for at least 8.3 h/day to achieve acceptable language development.

A novel cochlear measurement that predicts inner-ear malformation.

The A-value used in cochlear duct length (CDL) estimation does not take malformed cochleae into consideration. The objective was to determine the A-value reported in the literature, to assess the accuracy of the A-value measurement and to evaluate a novel cochlear measurement in distinguishing malformed cochlea. High resolution Computer Tomography images in the oblique coronal plane/cochlear view of 74 human temporal bones were analyzed. The A-value and novel C-value measurement were evaluated as predictors of inner ear malformation type. The proximity of the facial nerve to the basal turn was evaluated subjectively. 26 publications report on the A-value; but they do not distinguish normal vs. malformed cochleae. The A-values of the normal cochleae compared to the cochleae with cochlear hypoplasia, incomplete partition (IP) type I, -type II, and -type III were significantly different. The A-value does not predict the C-value. The C-values of the normal cochleae compared to the cochleae with IP type I and IP type III were significantly different. The proximity of the facial nerve to the basal turn did not relate to the type of malformation. The A-value is different in normal vs. malformed cochleae. The novel C-value could be used to predict malformed anatomy, although it does not distinguish all malformation types.

Consistency of Using an Auditory Prosthesis Device Post a Sequentially Implanted Cochlear Implant: Data-Logging Evidence.

Objectives The aim of this study was to explore: 1) the average use of each device in sequentially implanted cochlear implants; 2) whether the inter-implant duration between implants produced any significant difference in the average use of the second implant; and 3) whether wearing hearing aids before the implantation of the second cochlear implant affects its average use. Materials and methods The study included 20 participants with bilateral Nucleus 24 implants (Cochlear Corporation, Lone Tree, CO). Data regarding various variables were extracted and then analyzed with IBM SPSS Statistics for Mac, version 23 (IBM Corp., Armonk, NY). Results The pediatric group included 14 subjects (average age 7.5 years) while the adult group comprised six subjects (average age 37.5 years). The average use of the second device was 0.9 hours per day more than the first in the pediatric group while it was 1.22 hours per day more in the adult group. We also divided the subjects on the basis of duration between the first and second devices and calculated the average use of each device by them. There was no significant difference (p>0.05). The average use by subjects who did and did not use hearing aids before implantation was also insignificant (p>0.05). Conclusions No significant difference between the average use of the first and second implants, between the inter-implant duration of the first and second implants, the average use of the second implant, and between using hearing aids before the implantation of the second device and the average use was observed.

Auditory Performance and Subjective Satisfaction with the ADHEAR System.

BACKGROUND: The ADHEAR device, a new nonsurgical bone conduction hearing device, has been developed for patients with conductive hearing loss. OBJECTIVES: This study aims to assess the impact of the ADHEAR device on the audiological performance and satisfaction level in subjects with conductive hearing loss. METHODS: Twelve patients with conductive hearing loss were included. All patients received the device for 3 months. The audiological outcomes were determined using basic audiological assessments, including pure tone audiometry and sound field measurements of pure tone and speech audiometry with the contralateral ear occluded with a specific earplug. Additionally, the patients were subjectively evaluated using (1) the Speech, Spatial, and Qualities Questionnaire (SSQ), and (2) the custom-made ADHEAR questionnaire. RESULTS: Analysis of the measured audiological outcomes revealed an average improvement in pure tone thresholds (functional gain) of 23 (± 4.4) dB HL when the ADHEAR system was used compared to the unaided condition in the sound field. Moreover, speech reception thresholds improved by an average of 23 (± 15.3) dB SPL in the aided condition with plugged contralateral ear. Additionally, when using ADHEAR in the sound field, subjects' speech recognition scores improved by 32% (± 17.7) in quiet and 21% (± 15.1) in the presence of interfering noise. The average SSQ questionnaire scores improved from 3.9 at the study initiation to 6.6 after 3 months of device usage. ADHEAR custom questionnaire assessments revealed high satisfaction and acceptance of the device with no pain or skin irritation. CONCLUSION: During the study period, this new adhesive system yielded improved audiological outcomes with high patient satisfaction and acceptance and no reported skin irritation or pain.