Staged implantation of active transcutaneous bone conduction hearing devices (BCHD) after explantation of older generation bone anchored hearing aids (BAHAs): Surgical outcomes and approach to management.

PURPOSE: To evaluate outcomes following explantation of percutaneous or transcutaneous bone conduction implants (pBCIs or tBCIs) and subsequent implantation of transcutaneous active bone conduction hearing devices (BCHDs); to provide guidance regarding staging of surgery and adjunctive procedures. MATERIALS AND METHODS: Retrospective chart review of eight adult subjects (ten ears) with pBCIs or tBCIs who underwent explantation of their device and subsequent implantation with a BCHD [MED-EL BONEBRIDGE™ (n = 7, 70 %) or Cochlear™ Osia® (n = 3, 30 %)]. RESULTS: Reasons for pBCI or tBCI explantation were pain (60 %, 6/10), infection (60 %, 6/10), skin overgrowth (50 %, 5/10), and inability to obtain new processors (20 %, 2/10). Median time between pBCI or tBCI removal and BCHD staged implant was 4.7 (IQR 2.2-8.1) months. Two subjects developed complications following BCHD implantation. One had a persistent wound overlying the osseointegrated screw after removal of the pBCI abutment, requiring removal and temporalis rotational flap. Staged Osia® implantation was performed, but ultimately wound dehiscence developed over the device. The second subject experienced an infection after BONEBRIDGE™ implantation (32 days after pBCI explant), necessitating washout and treatment with intravenous antibiotics. There was subsequent device failure. CONCLUSION: The transition from a pBCI or tBCI to a novel transcutaneous device is nuanced. Staged pBCI or tBCI explantation and novel BCHD implantation with sufficient time for wound healing is vital. Adjunctive procedures to augment soft tissue in cases of prior attenuation may be required to avoid complications with larger internal devices.

Surgical results of transcutaneous bone-anchored hearing aid comparing the C-shaped and linear incision techniques.

PURPOSE: The aim of the study is to compare the operative time and postoperative complication outcomes for bone-anchored hearing aid (BAHA) implants using two different techniques: the C-shaped incision technique and the linear incision technique. METHODS: An analysis was carried out of 38 patients implanted with transcutaneous BAHAs during a 4-year period in a single otolaryngology department. RESULTS: The implantation was carried out under general anesthesia. Operative time was significant lower with the linear technique compared to the C-shaped technique (76.55 min, SD 16.75 vs. 93.17 min, SD 19.82; p = 0.007). There was no difference in postoperative complications between the two techniques. CONCLUSIONS: The use of linear incision for transcutaneous BAHA system implantation is associated with a reduced surgery time compared to the C-shaped technique, with no increase in postoperative complications.

Dementia and hearing-aid use: a two-way street.

OBJECTIVES: Hearing-aid use may reduce risk of dementia, but cognitive impairment makes use more challenging. An observed association between reduced hearing-aid use and incident dementia could reflect either or both of these causal paths. The objective was to examine the effects of each path while minimising contamination between paths. METHODS: Health records data from 380,794 Veterans who obtained hearing aids from the US Veterans Affairs healthcare system were analysed. Analysis 1 (n = 72,180) used multivariable logistic regression to model the likelihood of incident dementia 3.5-5 years post hearing-aid fitting for patients free of dementia and mild cognitive impairment (MCI). Analysis 2 (n = 272,748) modelled the likelihood of being a persistent hearing-aid user at 3 years 2 months after fitting, contrasting subgroups by level of cognitive function at the time of fitting. Analysis time windows were optimized relative to dataset constraints. Models were controlled for available relevant predictors. RESULTS: The adjusted OR for incident dementia was 0.73 (95% CI 0.66-0.81) for persistent (versus non-persistent) hearing-aid users. The adjusted OR for hearing-aid use persistence was 0.46 (95% CI 0.43-0.48) in those with pre-existing dementia (versus those remaining free of MCI and dementia). CONCLUSION: Substantial independent associations are observed in both directions, suggesting that hearing-aid use decreases risk of dementia and that better cognitive function predisposes towards persistent use. Research studying protective effects of hearing-aid use against dementia needs to account for cognitive status. Clinically, hearing devices and hearing care processes must be accessible and usable for all, regardless of their cognitive status.

Foreign Body Complications in Ears due to Mishandled Hearing Aid Fitting and Proposed Clinical Guidelines to Address the Complications.

BACKGROUND: South Korea has one of the world's fastest aging populations and is witnessing increased age-related hearing impairment cases as well as an increase in the number of hearing aid users. The aim of this study was to analyze complications caused by hearing aid mold materials. In addition, we hope to raise awareness of the harm and danger that inexperienced hearing aid providers can cause to patients. METHODS: We retrospectively reviewed the medical records of 11 patients who were diagnosed with hearing aid mold material as a foreign body in the ear at a tertiary center between 2016 and 2020. The following data were analyzed: symptoms, endoscopic findings, audiometry, temporal bone CT images, treatment methods, and complications after removal. The currently available literature was also reviewed to develop clinical guidelines, to identify the systematic weaknesses in the South Korean hearing aid market, and to identify policies that warrant better quality control. RESULTS: Among the 11 cases, 9 were restricted to the external auditory canal, all of which were successfully removed under endoscopy with minor complications. Two cases with middle ear involvement resulted in infection and thus required surgical removal with mastoidectomy. The average age of these patients was 76.4, and all patients received their molding procedure at private hearing aid shops without an otolaryngologist's examination. CONCLUSION: Thorough patient history-taking and otologic examination must be performed to identify patients at higher risk of complications. Such patients should be referred to an otolaryngologist. If a patient exhibits alarming symptoms, early referral is critical since prompt surgery can minimize complications. A CT scan is highly recommended to determine an optimal approach for foreign body removal. Systematic and regulatory changes in hearing aid dispensers, such as requiring apprenticeship, raising the required level of education, and legally mandating referrals, can help reduce these complications.

Adverse events associated with bone-conduction and middle-ear implants: a systematic review.

PURPOSE: To review types and frequencies of adverse events (AE) associated with bone-conduction hearing implants (BCHIs) and active middle-ear implants (aMEIs) as reported in the literature. METHODS: Cochrane, PubMed, and EMBASE libraries were searched for primary articles in English or German language that reported on adverse events following BCHI or aMEI implantation, included at least five patients and were published between 1996 and 2016. Study characteristics, demographics, and counts of adverse events were tabulated and analyzed within the R statistical programming environment. RESULTS: Following assessment of the reporting quality of adverse events, we present a brief guideline that potentially improves AE reporting in this field of research. For the full dataset, we summarize study-level adverse event frequencies in terms of ratio of events to ears (REE) by AE groups and by device. For a subset of studies, we also report cumulative incidence (risk) for minor- and major adverse-events by device and by device groups. CONCLUSIONS: Data analyzed in this review show that: (1) the reporting quality of adverse events associated with BCHI and aMEIs is often very low; (2) adverse events associated with BCHI and aMEIs are qualitatively different and not equally frequent among devices; (3) state-of-the-art implantable BCHIs and aMEIs are a safe treatment option for hearing loss.

Investigating the prevalence and impact of device-related problems associated with hearing aid use.

Objective: To explore the prevalence of device-related problems associated with hearing aid use, participants' help-seeking behaviours for these problems, and factors associated with hearing aid problems.Design: A prospective convenience cohort design surveying 413 adult hearing aid users (34-97 years of age) recruited from seven clinics across Australia.Results: Almost all participants (98%) indicated that they were experiencing at least one of the hearing aid problems included on the survey. The number of hearing aid related problems reported by participants ranged from 0 to 25 (of a possible 26), with a mean of 10 problems (SD = 5). The three most reported problems were related to difficulty hearing in noisy environments, hearing in windy environments, and understanding certain voices. Participants had reported less than half (46.33%) of the total problems identified to their clinic (range = 0-100%, mean = 43.40, SD = 13.92). Participants who reported experiencing a greater number of hearing aid problems also reported lower levels of hearing aid benefit, and satisfaction with their hearing aids.Conclusions: The majority of hearing aid owners experience problems with their hearing aids. Addressing these problems would likely contribute to improved hearing aid outcomes.

On the limitations of sound localization with hearing devices.

Limited abilities to localize sound sources and other reduced spatial hearing capabilities remain a largely unsolved issue in hearing devices like hearing aids or hear-through headphones. Hence, the impact of the microphone location, signal bandwidth, different equalization approaches, as well as processing delays in superposition with direct sound leaking through a vent was addressed in this study. A localization experiment was performed with normal-hearing subjects using individual binaural synthesis to separately assess the above-mentioned potential limiting issues for localization in the horizontal and vertical plane with linear hearing devices. To this end, listening through hearing devices was simulated utilizing transfer functions for six different microphone locations, measured both individually and on a dummy head. Results show that the microphone location is the governing factor for localization abilities with linear hearing devices, and non-optimal microphone locations have a disruptive influence on localization in the vertical domain, and an effect on lateral sound localization. Processing delays cause additional detrimental effects for lateral sound localization; and diffuse-field equalization to the open-ear response leads to better localization performance than free-field equalization. Stimuli derived from dummy head measurements are unsuited for evaluating individual localization abilities with a hearing device.

Communication and Healthcare: Self-Reports of People with Hearing Loss in Primary Care Settings.

Objectives: To assess the experiences of people with hearing loss in healthcare environments to characterize miscommunication and unmet needs, and guide recommendations for improving outcomes and access. Methods: Anonymous survey developed by subject-matter experts was posted on a large national hearing-loss consumer and advocacy organization website and email listserv. Data were collected and managed via RedCAP. Results: Responses were received from 1581 individuals. Respondents reported moderate or significant difficulty communicating with all listed providers. Three communication situations emerged as often presenting communication difficulties: hearing one's name when called in the waiting room, hearing when the speaker's back was turned, and hearing when communicating by telephone. Despite 93% of respondents indicating they sometimes or often let providers know about their hearing loss, 29.3% of all respondents still reported that no arrangements were made to improve communication. Conclusions: This study clearly demonstrates the ongoing difficulties faced by individuals with hearing loss, particularly older adults, as they attempt to navigate both providers and situations associated with a typical primary care office visit. Clinical Implications: Inexpensive and efficient changes to improve communication include (1) Improving one-on-one provider communication by facing the individual with good lighting, clear speaking, and not obstructing one's mouth; (2) Environmental changes such as using visual or tactile alerting devices in waiting rooms and adding noise-dampening carpeting and curtains; and (3) Avoiding telephones and conveying health information in writing.

[Analysis and Some Thoughts on Safety Evaluation of Hearing Aids].

Based on analysis of the domestic and foreign laws and regulations for hearing aids,some suggestions of safety evaluation about standards,premarket technical review and regulation are presented in this article.It is hoped to be helpful for registration and regulation of hearing aids.

Listening through hearing aids affects spatial perception and speech intelligibility in normal-hearing listeners.

Cubick and Dau [(2016). Acta Acust. Acust. 102, 547-557] showed that speech reception thresholds (SRTs) in noise, obtained with normal-hearing listeners, were significantly higher with hearing aids (HAs) than without. Some listeners reported a change in their spatial perception of the stimuli due to the HA processing, with auditory images often being broader and closer to the head or even internalized. The current study investigated whether worse speech intelligibility with HAs might be explained by distorted spatial perception and the resulting reduced ability to spatially segregate the target speech from the interferers. SRTs were measured in normal-hearing listeners with or without HAs in the presence of three interfering talkers or speech-shaped noises. Furthermore, listeners were asked to sketch their spatial perception of the acoustic scene. Consistent with the previous study, SRTs increased with HAs. Spatial release from masking was lower with HAs than without. The effects were similar for noise and speech maskers and appeared to be accounted for by changes to energetic masking. This interpretation was supported by results from a binaural speech intelligibility model. Even though the sketches indicated a change of spatial perception with HAs, no direct link between spatial perception and segregation of talkers could be shown.

Mild-moderate congenital hearing loss: secular trends in outcomes across four systems of detection.

BACKGROUND: Universal newborn hearing screening (UNHS) targets moderate or greater hearing loss. However, UNHS also frequently detects children with mild loss that results in many receiving early treatment. The benefits of this approach are not yet established. We aimed to (i) compare language and psychosocial outcomes between four hearing loss detection systems for children aged 5-8 years with congenital mild-moderate hearing loss; (ii) determine whether age of detection predicts outcomes; and (iii) compare outcomes between children identified via well-established UNHS and the general population. METHODS: Linear regression adjusted for potential confounding factors was used throughout. Via a quasi-experimental design, language and psychosocial outcomes were compared across four population-based Australian systems of hearing loss detection: opportunistic detection, born 1991-1993, n = 50; universal risk factor referral, born 2003-2005, n = 34; newly established UNHS, born 2003-2005, n = 41; and well-established UNHS, born 2007-2010, n = 21. In pooled analyses, we examined whether age of detection predicted outcomes. Outcomes were similarly compared between the current well-established UNHS system and typically developing children in the Early Language in Victoria Study, born 2003, n = 1217. RESULTS: Age at diagnosis and hearing aid fitting fell steadily across the four systems. For moderate losses, mean expressive language (P for trend .05) and receptive vocabulary (P for trend .06) improved across the four systems, but benefit was not obvious for mild losses. In pooled analyses, diagnosis before age six months predicted better language outcomes for moderate losses. Children with mild-moderate losses exposed to well-established UNHS continue to experience expressive language scores well below children in the general population (adjusted mean difference -8.9 points, 95% CI -14.7 to -3.1). CONCLUSIONS: Treatment arising from UNHS appears to be clearly benefitting children with moderate hearing losses. However, rigorous trials are needed to quantify benefits, versus costs and potential harms, of early aiding of children with mild losses.

Hearing Aids and Health-Related Quality of Life in Adults With Hearing Loss.

Clinical Question: Are hearing aids associated with improved health-related quality of life in adults with mild to moderate hearing loss? Bottom Line: Compared with no hearing aids, the provision of hearing aids was associated with improvements in hearing-specific and general health-related quality of life.

Hearing aids for mild to moderate hearing loss in adults.

BACKGROUND: The main clinical intervention for mild to moderate hearing loss is the provision of hearing aids. These are routinely offered and fitted to those who seek help for hearing difficulties. By amplifying and improving access to sounds, and speech sounds in particular, the aim of hearing aid use is to reduce the negative consequences of hearing loss and improve participation in everyday life. OBJECTIVES: To evaluate the effects of hearing aids for mild to moderate hearing loss in adults. SEARCH METHODS: The Cochrane ENT Information Specialist searched the ENT Trials Register; the Cochrane Register of Studies Online; MEDLINE; PubMed; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 March 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) of hearing aids compared to a passive or active control in adults with mild to moderate hearing loss. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes in this review were hearing-specific health-related quality of life and the adverse effect pain. Secondary outcomes were health-related quality of life, listening ability and the adverse effect noise-induced hearing loss. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included five RCTs involving 825 participants. The studies were carried out in the USA and Europe, and were published between 1987 and 2017. Risk of bias across the studies varied. Most had low risk for selection, reporting and attrition bias, and a high risk for performance and detection bias because blinding was inadequate or absent.All participants had mild to moderate hearing loss. The average age across all five studies was between 69 and 83 years. The duration of the studies ranged between six weeks and six months.There was a large beneficial effect of hearing aids on hearing-specific health-related quality of life associated with participation in daily life as measured using the Hearing Handicap Inventory for the Elderly (HHIE, scale range 1 to 100) compared to the unaided/placebo condition (mean difference (MD) -26.47, 95% confidence interval (CI) -42.16 to -10.77; 722 participants; three studies) (moderate-quality evidence).There was a small beneficial effect of hearing aids on general health-related quality of life (standardised mean difference (SMD) -0.38, 95% CI -0.55 to -0.21; 568 participants; two studies) (moderate-quality evidence). There was a large beneficial effect of hearing aids on listening ability (SMD -1.88, 95% CI -3.24 to -0.52; 534 participants; two studies) (moderate-quality evidence).Adverse effects were measured in only one study (48 participants) and none were reported (very low-quality evidence). AUTHORS' CONCLUSIONS: The available evidence concurs that hearing aids are effective at improving hearing-specific health-related quality of life, general health-related quality of life and listening ability in adults with mild to moderate hearing loss. The evidence is compatible with the widespread provision of hearing aids as the first-line clinical management in those who seek help for hearing difficulties. Greater consistency is needed in the choice of outcome measures used to assess benefits from hearing aids. Further placebo-controlled studies would increase our confidence in the estimates of these effects and ascertain whether they vary according to age, gender, degree of hearing loss and type of hearing aid.

Hearing aid silicone impression material as a foreign body in the middle ear.

We report an extremely rare case of hearing aid silicone impression material as a foreign body in the middle ear. Symptoms of the patient were otorrhea and vertigo after taking of a mold impression on his only hearing ear, and the symptoms mimicked chronic otitis media. A temporal bone CT scan revealed foreign body material in the middle ear and Eustachian tube. An intact canal wall mastoidectomy with a facial recess approach and type IV tympanoplasty was performed to remove the silicone impression material. In addition to the case report, we review the literature regarding impression material foreign bodies.

Safety limit warning levels for the avoidance of excessive sound amplification to protect against further hearing loss.

OBJECTIVE: To determine safe output sound pressure levels (SPL) for sound amplification devices to preserve hearing sensitivity after usage. DESIGN: A mathematical model consisting of the Modified Power Law (MPL) (Humes & Jesteadt, 1991 ) combined with equations for predicting temporary threshold shift (TTS) and subsequent permanent threshold shift (PTS) (Macrae, 1994b ) was used to determine safe output SPL. STUDY SAMPLE: The study involves no new human subject measurements of loudness tolerance or threshold shifts. PTS was determined by the MPL model for 234 audiograms and the SPL output recommended by four different validated prescription recommendations for hearing aids. RESULTS: PTS can, on rare occasion, occur as a result of SPL delivered by hearing aids at modern day prescription recommendations. The trading relationship of safe output SPL, decibel hearing level (dB HL) threshold, and PTS was captured with algebraic expressions. Better hearing thresholds lowered the safe output SPL and higher thresholds raised the safe output SPL. CONCLUSION: Safe output SPL can consider the magnitude of unaided hearing loss. For devices not set to prescriptive levels, limiting the output SPL below the safe levels identified should protect against threshold worsening as a result of long-term usage.

A systematic review on skin complications of bone-anchored hearing aids in relation to surgical techniques.

A systematic review to study the skin complications associated with the bone-anchored hearing aid in relation to surgical techniques. The following databases have been searched: MEDLINE, EMBASE, the Cochrane Library , Google scholar and the PubMed. The literature search date was from January 1977 until November 2013. Randomised controlled trials and retrospective studies were included. Initial search identified 420 publications. Thirty articles met the inclusion criteria of this review. The most common surgical techniques identified were full-thickness skin graft, Dermatome and linear incision techniques. The result shows that dermatome technique is associated with higher rate of skin complications when compared to linear incision and skin graft techniques. Based on the available literature, the use of a linear incision technique appears to be associated with lower skin complications; however, there is limited data available supporting this. Higher quality studies would allow a more reliable comparison between the surgical techniques.

Predisposing factors for adverse skin reactions with percutaneous bone anchored hearing devices implanted with skin reduction techniques.

We present an analysis of adverse events after implantation of bone anchored hearing device in our patient population with focus on individual risk factors for peri-implant skin reactions. The investigation involved a chart review of adult Baha patients (n = 179) with 203 Bahas implanted with skin reduction techniques between 1993 and 2009, a questionnaire (n = 97) and a free clinical examination (n = 47). Skin reactions were graded by severity from 0 (no skin reaction) to 4 (implant loss resulting from infection) according to Holgers. We analyzed the skin reaction rate (SRR) defined as the number of skin reactions per year and the worst Holgers grade (WHG), which indicates the grade of the worst skin reaction per implant. We defined 20 parameters including the demographic characteristics, surgery details, subjective benefits, handling and individual factors. The most frequent adverse events (85 %) were skin reactions. The average SRR was 0.426 per Baha year. Six parameters showed an association with the SRR or the WHG. The clinically most relevant factors are an elevated Body Mass Index (BMI, p = 0.02) and darker skin type (p = 0.03). The SRR increased with the distance between the tragus and the implant (p = 0.02). Regarding the identified risk factors, the SRR might be reduced by selecting a location for the implant near the pinna and by specific counseling regarding post-operative care for patients with darker skin type or an elevated Body Mass Index (BMI). Few of the factors analyzed were found to influence the SRR and WHG. Since most adverse skin reactions could be treated easily with local therapy, our results suggest that in adult patients, individual risk factors for skin reactions are not a contraindication for Baha implantation. Thus, patients can be selected purely on audiological criteria.

Laser-Doppler microvascular measurements in the peri-implant areas of different osseointegrated bone conductor implant systems.

The objective of this study was to evaluate the impact of hydroxyapatite coating of newly designed osseointegrated fixtures' abutments on the postoperative complication rates. The integrity of peri-implant microcirculation was used as a marker to compare tissue viability after different surgical techniques. Laser-Doppler Flowmetry (LDF) measures alone, and coupled with heat provocation tests were applied to test the different microcircular patterns. Measures for 17 consecutively implanted patients (8 women, 9 men, ages ranged from 18 to 77 years) were recruited; seven with soft tissue reduction (STR); and 10 with soft tissue preservation (STP).Thirteen non-operated retro-auricular areas were examined as naive controls. In isotherm conditions the baseline blood flow remained stable in all groups. The naive control patients demonstrated significant changes of blood flux in the intact skin. The non-implanted yet previously operated contralateral sides of the patients demonstrated marginally lower (p = 0.09) blood flux index. The STR sides however, showed significantly lower (average 217 %) provoked blood flux compared to controls (p < 0.001). At the STP sides a maladaptation could be observed (average 316 %) compared to the contralateral sides (p = 0.53). STP sides demonstrated a significantly better blood flow improvement compared to the STR sides (p = 0.02). These results suggest a favorable postoperative condition of vascular microcirculation after STP, than after STR surgery. The possibly faster wound healing and lower potential complication rate may widen the inclusion criteria and maybe beneficial for the patient compliance with a better quality-of-life.

Complications and audiological results of percutaneous bone-anchored hearing devices.

OBJECTIVE: To describe the post-operative complications and audiological results related to percutaneous bone-anchored hearing devices. METHODS: A retrospective review was conducted of 44 patients with bilateral conductive or mixed hearing loss who were implanted with unilateral Baha Connect or Ponto devices. A generalised linear model for repeated measurements was used. RESULTS: Twenty patients were Baha Connect users, and 24 were implanted with Ponto devices. Twenty-seven patients experienced complications. No fewer complications were found in the group of patients using longer abutments. When we compared the frequency of complications between Ponto and Baha Connect users, there was no statistically significant difference (p = 0.90). Free-field hearing thresholds were statistically significantly improved when we compared pre- and post-operative results (p < 0.001). Average speech perception also improved (p < 0.001). CONCLUSION: Despite percutaneous bone-anchored hearing devices having a high rate of complications, they provide significant audiological benefits.