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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Consumer and audiologist perspectives on hearables: a qualitative study.

OBJECTIVE: We aimed to explore (i) what adults with hearing difficulties want and need from hearables, which we defined as any non-medical personal sound amplification product, and (ii) what hearing care professionals think about hearables. DESIGN: This was an exploratory, qualitative study conducted using separate focus groups with adults with hearing difficulties and audiologists. Data were analysed inductively using reflexive thematic analysis. STUDY SAMPLE: Participants were 12 adults with hearing difficulties and 6 audiologists. RESULTS: Adults with hearing difficulties expressed desire for trustworthy information and support, described evaluating hearables and other devices according to diverse personal criteria, and expressed willingness to vary their budget according to product quality. Audiologists expressed views that hearables are an inferior product but useful tool, that it is not necessarily their role to assist with hearables, that hearables are a source of uncertainty, and that the provision of hearables by audiologists is not currently practical. CONCLUSION: Adults with hearing difficulties may have complex reasons for considering hearables and may desire a high level of clinical support in this area. Ongoing research into the efficacy and effectiveness of hearables is needed together with research into effective strategies to incorporate hearables into clinical practice.

Hearing and Speech Perception for People With Hearing Loss Using Personal Sound Amplification Products.

BACKGROUND: Hearing loss (HL) is the most common chronic disease and has been linked to negative health outcomes. Hearing aids (HAs) are regarded as the gold standard for HL management, however, the adoption rate of HAs is relatively low for various reasons. With this background, hearing devices, such as personal sound amplification products (PSAPs) received significant attention as an alternative to conventional HAs. This study aimed to evaluate the clinical efficacy of PSAPs in patients with mild to moderately severe HL. METHODS: Nineteen patients with mild hearing loss (MHL), 23 with moderate hearing loss (MDHL), and 15 with moderately severe hearing loss (MSHL) participated in the study. Electroacoustic analysis, simulated real-ear measurements (REMs), and three clinical evaluations were implemented. RESULTS: All devices satisfied the electroacoustic tolerances. All devices provided sufficient gain for MHL and MDHL audiograms. However, in MSHL audiogram, the gains of PSAPs were insufficient, especially for high frequencies. In terms of clinical evaluations, sound-field audiometry showed significant improvements between aided and unaided thresholds in all groups for all devices (P < 0.001). Significant improvements of word recognition scores were only shown for HAs between aided and unaided conditions. The Korean version of the Hearing In Noise Test did not show any consistent findings for all devices and groups. CONCLUSION: Certain PSAPs are beneficial for improving hearing and speech perception in patients with HL. Well-chosen PSAPs could be an alternative hearing rehabilitation option for these patients.

Consensus on connected hearing health technologies and service delivery models in the UK: a Delphi review.

OBJECTIVE: To develop a consensus among hearing healthcare professionals in the UK on connected hearing health technologies and service delivery models. DESIGN: A three-round, electronic Delphi review was developed using a participatory-design approach. This included ten open-ended questions (round one) that informed 69 Likert-scaled statements (rounds two and three). STUDY SAMPLE: An expert panel of 34 hearing health professionals representing all geographic regions of the UK from either the publicly funded National Health Service (n = 22) or independent sector (n = 12). RESULTS: The majority of statements (61%) showed ≥80% consensus, highlighting that there was broad agreement amongst professionals on connected hearing health technologies. For example, there was consensus that adults who report communication difficulties and have no medical contraindications would be ideal candidates. Furthermore, it was unanimously agreed that connected technologies could result in delays in diagnosis of treatable medical conditions, as well as result in inadequate amplification. Overall, the expert panel concurred that connected technologies could serve as "gateway products" that lead to earlier hearing aid uptake. CONCLUSIONS: This Delphi review identified overarching areas of agreement that may serve as a blueprint for future implementation of connected hearing health technologies through either conventional or new service delivery models in the UK.

A systematic review and meta-analysis assessing the effectiveness of alternative listening devices to conventional hearing aids in adults with hearing loss.

Recent technological advances have led to a rapid increase in alternative listening devices to conventional hearing aids. The aim was to systematically review the existing evidence to assess the effectiveness of alternative listening devices in adults with mild and moderate hearing loss. A systematic search strategy of the scientific literature was employed, reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) checklist. Eleven studies met eligibility for inclusion: two studies evaluated personal sound amplification products, and nine studies assessed remote microphone systems (frequency modulation, Bluetooth, wireless). The evidence in this review suggests that alternative listening devices improve behavioural measures of speech intelligibility relative to unaided and/or aided conditions. Evidence for whether alternative listening devices improve self-reported outcomes is inconsistent. The evidence was judged to be of poor to good quality and subject to bias due to limitations in study design. Our overall recommendation is that high-quality evidence (i.e. randomised controlled trials) is required to demonstrate the effectiveness of alternative listening devices. Such evidence is not currently available and is necessary to guide healthcare commissioners and policymakers when considering new service delivery models for adults with hearing loss. Review registration: Prospective Register of Systematic Reviews (PROSPERO), CRD42015029582.

Apple AirPods Pro as a Hearing Assistive Device in Patients with Mild to Moderate Hearing Loss.

PURPOSE: This study aimed to assess the feasibility of the Apple AirPods Pro with the headphone accommodation feature as a hearing assistive device for patients with mild to moderate hearing loss (HL). MATERIALS AND METHODS: The study included a total of 35 participants with mild to moderate HL. To determine the degree of HL in the participants, a screening test using pure-tone audiometry was conducted prior to the main tests of functional gain, word recognition score (WRS), and sentence recognition in noisy environments. The study employed two hearing devices: the Bean (a personal sound amplification product, PSAP) and the AirPods Pro. RESULTS: Regarding functional gain, there were no significant differences between the Bean and the AirPods Pro at all frequencies, except 8 kHz. In terms of WRS, both the Bean and the AirPods Pro had higher scores than the unaided condition. In sentence recognition, both the Bean and the AirPods Pro had higher scores than the unaided condition. During real-ear measurement, the Bean demonstrated consistent frequency responses, while the AirPods had a deviation exceeding 10 dB SPL at 6 kHz in the left ear. This deviation was absent for all other frequencies. CONCLUSION: This study shows that the Apple AirPods Pro, with its headphone accommodation feature, performed similarly to a validated PSAP and improved hearing compared to unaided conditions.

Comparison of personal sound amplification products and conventional hearing aids for patients with hearing loss: A systematic review with meta-analysis.

Background: Hearing loss is a common morbidity that requires a hearing device to improve quality of life and prevent sequelae, such as dementia, depression falls, and cardiovascular disease. However, conventional hearing aids have some limitations, including poor accessibility and unaffordability. Consequently, personal sound amplification products (PSAPs) are considered a potential first-line alternative remedy for patients with hearing loss. The main objective of this study was to compare the efficacy of PSAPs and conventional hearing aids regarding hearing benefits in patients with hearing loss. Methods: This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Five databases and reference lists were searched from inception to January 12, 2022. Studies including randomised, controlled trials; nonrandomised, controlled trials; or observational studies comparing PSAPs and hearing aids with regard to hearing gain performance (e.g., speech intelligence) were considered eligible. The review was registered prospectively on PROSPERO (CRD42021267187). Findings: Of 599 records identified in the preliminary search, five studies were included in the review and meta-analysis. A total of 124 patients were divided into the PSAP group and the conventional hearing aid group. Five studies including seven groups compared differences for speech intelligence in the signal-noise ratio (SNR) on the hearing in noise test (HINT) between PSAPs and conventional hearing aids. The pooled results showed nonsignificant differences in speech intelligence (SMD, 0.14; 95% CI, -0.19 to 0.47; P = .41; I 2=65%), sound quality (SMD, -0.37; 95% CI, -0.87 to 0.13; P = .15; I 2=77%) and listening effort (SMD 0.02; 95% CI, -0.24 to 0.29; P = .86; I 2=32%). Nonsignificant results were also observed in subsequent analyses after excluding patients with moderately severe hearing loss. Complete sensitivity analyses with all of the possible combinations suggested nonsignificant results in most of the comparisons between PSAPs and conventional hearing aids. Interpretation: PSAPs are potentially beneficial as conventional hearing aids are in patients with hearing loss. The different features among PSAPs should be considered for patients indicated for hearing devices. Funding: This work was supported by grants from Ministry of Science and Technology (MOST-10-2622-8-075-001) and Veterans General Hospitals and University System of Taiwan Joint Research Program (VGHUST111-G6-11-2 and VGHUST111c-140).

Hearables as a Gateway to Hearing Health Care.

The market for hearing technology is evolving-with the emergence of hearables, it now extends beyond hearing aids and includes any ear-level devices with wireless connectivity (i.e., wireless earbuds). However, will this evolving marketplace bring forth opportunities or challenges to individuals' hearing health care and the profession of audiology and otolaryngology? The debate has been ongoing. This study explores the wide spectrum of hearables available in the market and discusses the necessity of high-quality clinical evidence prior to the implementation of over-the-counter devices into clinical practice.

Argumentum ad Ignorantiam: Smartphone-Connected Listening Devices.

In this article, we review the current literature assessing the application and benefits of connected hearing technologies, as well as their potential to improve accessibility to and affordability of hearing healthcare. Over the past decade, there has been a proliferation of hearing devices that connect wirelessly to smartphone technologies via Bluetooth. These devices include (1) smartphone-connected hearing aids that must be obtained from a licensed audiologist or hearing aid dispenser; (2) direct-to-consumer devices, such as personal sound amplification products; and (3) smartphone-based hearing aid applications (or apps). Common to all these connected devices is that they permit the user to self-adjust and customize their device programs via an accompanying smartphone app. There has been a growing body of literature assessing connected hearing devices in adults living with hearing loss. Overall, the evidence to date supports the notion that all connected hearing devices can improve accessibility to and affordability of amplification. It is unclear, however, whether connected technologies are a clinically effective alternative to traditional hearing aids. Even so, the impact of connectivity is especially pertinent given the sudden disruption caused by the recent global COVID-19 pandemic, whereby connected technologies enable patients to receive treatment through mobile-based, tele-audiology platforms.

Direct-to-Consumer Hearing Devices: Capabilities, Costs, and Cosmetics.

Direct-to-consumer (DTC) hearing devices can be purchased without consulting a hearing health professional. This project aims to compare 28 DTC devices with the most popular hearing aid supplied by the U.K. National Health Service (NHS). The comparison was based on technical performance, cosmetic acceptability, and the ability to match commonly used gain and slope targets. Electroacoustic performance was evaluated in a 2-cc coupler. Match to prescription target for both gain and slope was measured on a Knowles Electronic Manikin for Acoustic Research using a mild and also a moderate sloping hearing loss. Using an online blinded paired comparison of each DTC and the NHS reference device, 126 participants (50 were hearing aid users and 76 were nonhearing aid users) assessed the cosmetic appearance and rated their willingness-to-wear the DTC devices. The results revealed that higher purchase prices were generally associated with a better match to prescribed gain-frequency response shapes, lower distortion, wider bandwidth, better cosmetic acceptability, and higher willingness-to-wear. On every parameter measured, there were devices that performed worse than the NHS device. Most of the devices were rated lower in terms of aesthetic design than the NHS device and provided gain-frequency responses and maximum output levels that were markedly different from those prescribed for commonly encountered audiograms. Because of the absence or inflexibility of most of the devices, they have the potential to deliver poor sound quality and uncomfortably loud sounds. The challenge for manufacturers is to develop low-cost products with cosmetic appeal and appropriate electroacoustic characteristics.

Outcomes of Direct-to-Consumer Hearing Devices for People with Hearing Loss: A Review.

As the population of those with mild to moderate hearing loss increases the need remains for amplification solutions. There is a trend to offer alternative amplification options beyond traditional hearing aids. Due to reduced medical risk associated with the most common types of hearing loss (i.e., presbycusis and noise induced), many individuals with such audiological configurations may have success with direct-to-consumer hearing devices (DCHD). The current paper presents a literature review of studies focused on the outcomes of DCHDs for people with hearing loss. Search of electronic databases were used to identify relevant articles for review. Studies on outcomes of DCHDs mainly focused on older adults and reported consistently positive results in clinical and self-reported outcome measures. Improvements in auditory ability, communicative function, social engagement, quality of life, and reduction of self-reported hearing disability were observed. The nature of the direct-to-consumer method makes it challenging to design studies that will accurately represent outcomes for patients due to the extensive dissimilarities in patient journey and device selection options. Accordingly, a majority of the studies conducted on this topic are of low quality of evidence and only provide short-term (i.e., less than one year) outcomes. In addition, results may have been influenced by researcher and/or clinician involvement in choosing the devices and by provision of additional support (i.e., incorporation of a communication partner and communication strategies training). Overall, the literature suggests positive outcomes and self-reported benefit of DCHDs in older adults with hearing loss. However, additional research is needed in this area to verify outcomes.

The Future of Private Practice in Audiology.

Although private practice in audiology has evolved during the past 40 years, hearing aids have remained as a central component to success. This article will discuss present and future trends for the next 40 years, including parallels to other professions and the need to innovate beyond technology.