Real-World Effectiveness of Wearable Augmented Reality Device for Patients With Hearing Loss: Prospective Study.

Hearing loss limits communication and social activity, and hearing aids (HAs) are an efficient rehabilitative option for improving oral communication and speech comprehension, as well as the psychosocial comfort of people with hearing loss. To overcome this problem, over-the-counter amplification devices including personal sound amplification products and wearable augmented reality devices (WARDs) have been introduced. This study aimed to evaluate the clinical effectiveness of WARDs for patients with mild to moderate hearing loss. A total of 40 patients (18 men and 22 women) with mild to moderate hearing loss were enrolled prospectively in this study. All participants were instructed to wear a WARD, Galaxy Buds Pro (Samsung Electronics), at least 4 hours a day for 2 weeks, for amplifying ambient sounds. Questionnaires including the Korean version of the abbreviated profile of hearing aid benefit (K-APHAB) and the Korean adaptation of the international outcome inventory for hearing aids (K-IOI-HA) were used to assess personal satisfaction in all participants. Audiologic tests, including sound field audiometry, sound field word recognition score (WRS), and the Korean version of hearing in noise test (K-HINT), were administered to 14 of 40 patients. The tests were performed under two conditions: unaided and aided with WARDs. The mean age of the participants was 55.4 (SD 10.7) years. After 2 weeks of the field trial, participants demonstrated a benefit of WARDs on the K-APHAB. Scores of 3 subscales of ease of communication, reverberation, and background noise were improved significantly (P<.001). However, scores regarding aversiveness were worse under the aided condition (P<.001). K-IOI-HA findings indicated high user satisfaction after the 2-week field trial. On audiologic evaluation, the K-HINT did not show significant differences between unaided and aided conditions (P=.97). However, the hearing threshold on sound field audiometry (P=.001) and the WRS (P=.002) showed significant improvements under the aided condition. WARDs can be beneficial for patients with mild to moderate hearing loss as a cost-effective alternative to conventional hearing aids.

Han UG ，Lee JY ，Kim GY ，Jo M ，Lee J ，Bang KH ，Cho YS ，Hong SH ，Moon IJ ... -  《JMIR mHealth and uHealth》

Feasibility of a Smartphone-Based Hearing Aid App for Mild-to-Moderate Hearing Loss: Prospective Multicenter Randomized Controlled Trial.

Hearing loss is a growing health concern worldwide. Hearing aids (HAs) are the treatment of choice for hearing rehabilitation in most cases of mild-to-moderate hearing loss. However, many patients with hearing loss do not use HAs due to their high cost, stigma, and inaccessibility. Since smartphones are widely used, many apps that mimic the amplification function of HAs have been introduced. Smartphone-based HA apps (SHAAs) are affordable and easy to access. However, the audiological benefit of SHAAs has not been determined. We compared the audiological performance between an SHAA and a conventional HA in a prospective, multicenter randomized controlled trial. Patients with mild-to-moderate hearing loss were prospectively enrolled from 2 tertiary hospitals and randomly assigned to either an SHAA (Petralex; IT4YOU Corp LLC) or a conventional HA (Siya 1 miniRITE; Oticon A/S). For the cross-over study design, participants used the alternate device and repeated the same 2-month trial. Audiological measurements were obtained using hearing tests, real-ear measurements, and the hearing-in-noise test (HINT). Subjective satisfaction was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and International Outcome Inventory for Hearing Aids (IOI-HA). Overall, 63 participants were screened and 38 completed the study. In sound-field audiometry testing, the SHAA showed a 20- to 60-dB gain in the low-to-high frequencies of the hearing threshold level. The HA provided adequate gain in the middle-to-high frequencies (55, 65, and 75 dB in real-ear measurements), which is the sound level for most speaking volumes. However, the SHAA could not improve word recognition at 50 dB. The HA showed better audiological performance than the SHAA in both quiet and noisy conditions in the HINT. The IOI-HA scores were significantly improved by both the HA and SHAA versus unaided conditions. Among the SHAA users, 37% (14/38), 42% (16/38), 24% (9/38), and 32% (12/38) showed improvement in APHAB scores for ease of communication, reverberation, background noise, and aversiveness of sounds, respectively. There were no differences in adverse events between the 2 study groups. The HA showed better performance than the SHAA in word recognition and the HINT. However, the SHAA was significantly better than unaided hearing in terms of amplification. The SHAA may be a useful hearing assistance device for patients with mild-to-moderate hearing loss when listening to soft sounds in quiet conditions. The SHAA demonstrated poorer performance than the HA in the mid- to high-frequency sounds that are important for word recognition, sound quality, and hearing in noisy conditions. Further development of the signal technology of SHAAs is needed to improve the sound quality of mid- to high-frequency sounds and overcome noisy environments.

Jo S ，Park MK ，Seo JH ，Lee KE ，Han JS ，Lim JH ，Lee JH ，Oh SH ... -  《JMIR mHealth and uHealth》

Comparative Effectiveness of Personal Sound Amplification Products Versus Hearing Aids for Unilateral Hearing Loss: A Prospective Randomized Crossover Trial.

This study compared hearing outcomes with use of personal sound amplification products (PSAPs) and hearing aids (HAs) in patients with moderate to moderately severe unilateral hearing loss. Thirty-nine participants were prospectively enrolled, and randomly assigned to use either one HA (basic or premium type) or one PSAP (basic or high-end type) for the first 8 weeks and then the other device for the following 8 weeks. Participants underwent a battery of examinations at three visits, including sound-field audiometry, word recognition score (WRS), speech perception in quiet and in noise, real-ear measurement, and self-report questionnaires. Functional gain was significantly higher with HAs across all frequencies (P < 0.001). While both PSAPs and HAs improved WRS from the unaided condition, HAs were superior to PSAPs. The speech recognition threshold in quiet conditions and signal-to-noise ratio in noisy conditions were significantly lower in the HA-aided condition than in the PSAP-aided condition, and in the PSAP-aided condition than in the unaided condition. Subjective satisfaction also favored HAs than PSAPs in questionnaires, Abbreviated Profile of Hearing Aid Benefit, International Outcome Inventory for Hearing Aids, and Host Institutional Questionnaire. While PSAPs provide some benefit for moderate to moderately severe unilateral hearing loss, HAs are more effective. This underscores the potential role of PSAPs as an accessible, affordable first-line intervention in hearing rehabilitation, particularly for individuals facing challenges in accessing conventional HAs.

Kim MS ，Kim KH ，Choe G ，Park YH ... -  《-》

Sentence recognition in noise and perceived benefit of noise reduction on the receiver and transmitter sides of a BICROS hearing aid.

In the past, bilateral contralateral routing of signals (BICROS) amplification incorporated omnidirectional microphones on the transmitter and receiver sides and some models utilized noise reduction (NR) on the receiver side. Little research has examined the performance of BICROS amplification in background noise. However, previous studies examining contralateral routing of signals (CROS) amplification have reported that the presence of background noise on the transmitter side negatively affected speech recognition. Recently, NR was introduced as a feature on the receiver and transmitter sides of BICROS amplification, which has the potential to decrease the impact of noise on the wanted speech signal by decreasing unwanted noise directed to the transmitter side. The primary goal of this study was to examine differences in the reception threshold for sentences (RTS in dB) using the Hearing in Noise Test (HINT) in a diffuse listening environment between unaided and three aided BICROS conditions (no NR, mild NR, and maximum NR) in the Tandem 16 BICROS. A secondary goal was to examine real-world subjective impressions of the Tandem 16 BICROS compared to unaided. A randomized block repeated measures single blind design was used to assess differences between no NR, mild NR, and maximum NR listening conditions. Twenty-one adult participants with asymmetric sensorineural hearing loss (ASNHL) and experience with BICROS amplification were recruited from Washington University in St. Louis School of Medicine. Participants were fit with the National Acoustic Laboratories' Nonlinear version 1 prescriptive target (NAL-NL1) with the Tandem 16 BICROS at the initial visit and then verified using real-ear insertion gain (REIG) measures. Participants acclimatized to the Tandem 16 BICROS for 4 wk before returning for final testing. Participants were tested utilizing HINT sentences examining differences in RTS between unaided and three aided listening conditions. Subjective benefit was determined via the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire between the Tandem 16 BICROS and unaided. A repeated measures analysis of variance (ANOVA) was utilized to analyze the results of the HINT and APHAB. Results revealed no significant differences in the RTS between unaided, no NR, mild NR, and maximum NR. Subjective impressions using the APHAB revealed statistically and clinically significant benefit with the Tandem 16 BICROS compared to unaided for the Ease of Communication (EC), Background Noise (BN), and Reverberation (RV) subscales. The RTS was not significantly different between unaided, no NR, mild NR, and maximum NR. None of the three aided listening conditions were significantly different from unaided performance as has been reported for previous studies examining CROS hearing aids. Further, based on comments from participants and previous research studies with conventional hearing aids, manufacturers of BICROS amplification should consider incorporating directional microphones and independent volume controls on the receiver and transmitter sides to potentially provide further improvement in signal-to-noise ratio (SNR) for patients with ASNHL.

Oeding K ，Valente M 《-》

Assessment of Hearing Aid Benefit Using Patient-Reported Outcomes and Audiologic Measures.

To determine the contributions to hearing aid benefit of patient-reported outcomes and audiologic measures. Independent review was conducted on audiologic and patient-reported outcomes of hearing aid benefit collected in the course of a middle ear implant FDA clinical trial. Unaided and aided data were extracted from the preoperative profiles of 95 experienced hearing aid users, and the relationships between a patient-reported outcome and audiologic measures were assessed. The following data were extracted: unaided and aided pure-tone or warble-tone thresholds (PTA), word recognition in quiet (NU-6), Speech Perception in Noise (low-/high-context SPIN), and patient-reported benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB). Hearing aid benefit was defined as the difference in thresholds or scores between unaided and aided conditions, as measured in the sound field. Correlations were computed among audiologic measures and global APHAB and subscale scores of hearing aid benefit. Significant improvements in all audiologic measures and APHAB scores were observed comparing unaided to aided listening (all p < 0.001). However, correlations between audiologic and patient-reported measures of aided performance or hearing aid benefit were low-to-weak or absent. No significant correlations were found between aided audiologic measures (PTA, NU-6, SPIN) and any aided APHAB scores (all p > 0.0125), and significant relationships for hearing aid benefit were absent with only few exceptions. Hearing aid benefit defined by global APHAB using NU-6 and SPIN scores showed significant but weak positive correlations (r = 0.37, p < 0.001; r = 0.28, p = 0.005, respectively) and ease of communication APHAB subscale scores (r = 0.32, p < 0.001; r = 0.33, p = 0.001, respectively). Hearing aid benefit assessed with audiologic measures were poor predictors of patient-reported benefit. Thus, patient-reported outcomes may provide a unique assessment of patient-perceived benefit from hearing aids, which can be used to direct hearing aid programming, training, or recommendations of alternative hearing services.

Dornhoffer JR ，Meyer TA ，Dubno JR ，McRackan TR ... -  《-》