Long-term evaluation of development in patients with bilateral microtia using softband bone conducted hearing devices.

OBJECTIVE: The ability of early intervention with softband bone conducted hearing device (BCHD) to ensure normal development of speech, language and psychosocial situations remains undetermined. We aimed to evaluate auditory and speech development, as well as psychosocial situations of children with bilateral microtia fitted with a softband BCHD for 3-5 years. METHODS: The study included 53 patients with bilateral microtia and 53 sex- and age-matched children with normal hearing. Auditory development was evaluated using the Meaningful Auditory Integration Scale (MAIS) and Categories of Auditory Performance (CAP). Speech Intelligibility Rating (SIR) and Meaningful Use of Speech Scale (MUSS) were used to assess speech development. The psychometric properties of these patients were evaluated using Achenbach's Child Behavior Checklist (CBCL), and subjective benefits were measured using the Glasgow Children's Benefit Inventory (GCBI) questionnaire. RESULTS: The average unaided and aided hearing thresholds measured using VRA were 73.8 ± 5.1 dB HL and 30.5 ± 6.0 dB HL, respectively. The total MAIS scores of the patients were 89.6 ± 9.6% and 93.0 ± 8.8% of normal hearing children at the last follow-up. The CAP scores of the two groups were 6.5 ± 1.3 and 6.9 ± 0.3, respectively. The mean MUSS score of the patients and the control group were 31.9 ± 7.0 and 34.3 ± 6.0, respectively. The mean SIR score of the two groups were 4.6 ± 0.7 and 4.8 ± 0.4. CBCL found that only two patients could be considered problematic psychosocially. The average benefit score on the GCBI was 32.9 ± 29.3. CONCLUSIONS: Softband BCHD significantly improved auditory development in patients with bilateral microtia, with speech development reaching the level of normal hearing peers. No significant behavioral problems were found in the patients, with subjective evaluations showing that softband BCHD improved patient quality of life.

A new bone conduction hearing aid to predict hearing outcome with an active implanted device.

PURPOSE: We compared our historical medium-term data obtained with an active semi-implanted bone conduction device and the hearing results of a new passive bone conduction hearing device to determine its predictive value for the hearing results with the semi-implanted device. METHODS: The study sample was 15 patients with an active bone conduction implant (mean follow-up 26 months). Pure tone audiometry was performed with headphones, sound field speech audiometry was conducted unaided, and free-field speech audiometry was carried out with both the active bone conduction system and the passive device switched off. RESULTS: As compared with the unaided condition, speech reception was significantly improved with both devices. Comparison of speech reception threshold at 100% of word recognition showed no difference between the active and the passive device. At lower intensity the difference in speech perception was significant in the patients with monaural fitting (group A) and was non-statistically significant in those with binaural fitting (group B); the speech reception threshold at 50% of word recognition was 26.00 dB (± 10.22) with the active implant and 30.50 dB (± 7.98) with the passive device in group A (p = 0.047) and 24.00 dB (± 5.48) and 29.00 dB (± 2.24) in group B (p = 0.052), respectively. CONCLUSIONS: The hearing outcome after active bone conduction implant was comparable to published data. Compared with the unaided condition, speech recognition was significantly improved with the passive device. The device may also provide value to predict the hearing outcome with the implanted device, especially at higher intensities. LEVEL OF EVIDENCE: IV.

Extended-Wear Hearing Technology: The Nonimplantables.

A new category of hearing technology has emerged that comprises devices inserted deep into the ear canal. Although not implanted, they represent an extension of what is expected of a traditional hearing aid. There are advantages to these devices, but they are not suited for all individuals with hearing loss. This category consists of 2 devices currently available in the United States: Lyric (Phonak AG, Stafa, Switzerland) and Earlens (Earlens, Menlo Park, CA, USA).

Hearing Loss in the Elderly.

Presbycusis, or age-related hearing loss (ARHL), is the result of physiologic and pathologic changes associated with advancing age. ARHL presents typically with a high-frequency hearing loss, which contributes to greater trouble hearing consonants within words. Consonants convey the bulk of meaning within a word, and this loss of linguistic information results in complaints associated with ARHL. Hearing aids and cochlear implants significantly improve the lives of older adults with hearing loss, in particular, those with depression and dementia. Successful current research in gene therapy, pharmacotherapy, and stems cells holds the promise of being able to restore native cochlear function.

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid. Final order.

The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

[Device-based treatment of mixed hearing loss: An audiological comparison of current hearing systems]. / Apparative Therapie bei kombiniertem Hörverlust: Ein audiologischer Vergleich aktueller Hörsysteme.

BACKGROUND: Various different hearing systems are available for device-supported hearing rehabilitation of patients with mixed hearing loss. Using the recently introduced objective comparison criterion "maximum output" (i.e., the maximum output level of a hearing device), the indications for different hearing devices can be compared. OBJECTIVE: This article reviews important terms such as gain, dynamic range, and maximum output level-all of which are relevant for the selection of a hearing device. The experimental part of this study compares all currently available hearing devices and determines the range of their indication with respect to the maximum bone-conduction hearing threshold. MATERIALS AND METHODS: The maximum frequency-specific output levels reported in the literature for the Baha Cordelle 2, the Sophono Alpha 2, and the Bonebridge (measured at the skull simulator), as well as those of the Codacs and the Soundbridge (in-vivo measurements) are compared to the maximum output levels given in the datasheets of the BP110 Power, the Baha Cordelle 2, the Bonebridge, the Codacs, the Ponto Pro Power, and the Sophono Alpha 2. Using appropriate correction factors, the maximum dynamic range and thus the maximum indication based on the bone-conduction threshold was determined. RESULTS: In patients with mild sensorineural hearing loss, passive transcutaneous hearing or Bonebridge implants can achieve good audiological results. In the transition region to moderate hearing loss, percutaneous devices are applicable. Combined hearing loss with more pronounced sensorineural hearing loss is best treated with a Soundbridge or Codacs implant. In the latter case, the cochlear potential for speech recognition has to be explored and, where appropriate, cochlear implants considered as an alternative.

Over-the-Counter Hearing Aids: A Lost Decade for Change.

BACKGROUND: Hearing aids sold directly to consumers in retail stores or through the internet, without individual prescription by audiological professionals, are termed over-the-counter (OTC) devices. This study aimed to determine whether there was any change in the electroacoustic characteristics of OTC devices compared to research carried out a decade earlier. The previous results indicated that most OTC devices were low-frequency-emphasis devices and were unsuitable for elderly people with presbycusis, who were likely to be the major consumers of these products. METHODS: Ten OTC devices were selected and their electroacoustic performance was measured. Appropriate clients for the OTC devices were derived, using four linear prescription formulae, and OTC suitability for elderly persons with presbycusis was investigated. RESULTS: OTC electroacoustic characteristics were similar to those in the earlier study. Most OTC devices were not acoustically appropriate for potential consumers with presbycusis. Although several of the devices could match prescriptive targets for individuals with presbycusis, their poor electroacoustic performance--including ineffective volume control function, high equivalent input noise, and irregular frequency response--may override their potential benefit. CONCLUSION: The low-cost OTC devices were generally not suitable for the main consumers of these products, and there has been little improvement in the appropriateness of these devices over the past decade.

Medical devices; ear, nose, and throat devices; classification of the wireless air-conduction hearing aid. Final rule.

The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Safety of an intra-oral hearing device utilizing a split-mouth research design.

OBJECTIVE: The auditory deficits of Single Sided Deafness (SSD) can be treated effectively with a novel device, SoundBite, that delivers sound by applying imperceptible vibratory signals to the teeth (hereafter referred to as an intra-oral hearing device). The intra-oral hearing device is placed around two maxillary teeth and is similar to a small partial denture or retainer. The goal of this study was to report how this removable hearing device affects the oral structures. METHODS: Twenty-two SSD patients wearing an intra-oral hearing device were enrolled in a prospective study for six months. Differences (delta) between the device-anchoring teeth and the equivalent contralateral non-device teeth were evaluated with four dental parameters using a paired t-test. Hearing thresholds were evaluated as a function of alveolar bone support using linear regression. RESULTS: Compared to the non-device teeth, the hearing device teeth did not exhibit any increased recession (delta = 0.1 mm, p-value = 0.48), increased pocket depth (delta = 0.0 mm, p-value = 0.48), increased root resorption (delta = 4%, p-value = 0.43), or increased alveolar bone loss (delta = 0.0 %, p-value = 0.43). There was no association between the amount of alveolar support and hearing thresholds (delta = 0.2, p-value = 0.34). CONCLUSION: The intra-oral component of the hearing device did not adversely affect the dental structures of the subjects in this trial.

Adaptive environment classification system for hearing aids.

An adaptive sound classification framework is proposed for hearing aid applications. The long-term goal is to develop fully trainable instruments in which both the acoustical environments encountered in daily life and the hearing aid settings preferred by the user in each environmental class could be learned. Two adaptive classifiers are described, one based on minimum distance clustering and one on Bayesian classification. Through unsupervised learning, the adaptive systems allow classes to split or merge based on changes in the ongoing acoustical environments. Performance was evaluated using real-world sounds from a wide range of acoustical environments. The systems were first initialized using two classes, speech and noise, followed by a testing period when a third class, music, was introduced. Both systems were successful in detecting the presence of an additional class and estimating its underlying parameters, reaching a testing accuracy close to the target rates obtained from best-case scenarios derived from non-adaptive supervised versions of the classifiers (about 3% lower performance). The adaptive Bayesian classifier resulted in a 4% higher overall accuracy upon splitting adaptation than the minimum distance classifier. Merging accuracy was found to be the same in the two systems and within 1%-2% of the best-case supervised versions.

It's time we listened to our teeth: the SoundBite hearing system.

The SoundBite hearing system (Sonitus Medical, San Mateo, Calif) allows people with single-sided deafness to wear an intraoral device and a small microphone in the deaf ear to regain lost hearing. A piezoelectric activator in a small removable unilateral oral appliance conducts sound through the bone via the teeth to the good ear. The goal of this article is to introduce the SoundBite, a new bone-conduction hearing device, to dentists and orthodontists.

Statistically derived factors of varied importance to audiologists when making a hearing aid brand preference decision.

PURPOSE: To determine the amount of importance audiologists place on various items related to their selection of a preferred hearing aid brand manufacturer. RESEARCH DESIGN: Three hundred forty-three hearing aid-dispensing audiologists rated a total of 32 randomized items by survey methodology. RESULTS: Principle component analysis identified seven orthogonal statistical factors of importance. In rank order, these factors were Aptitude of the Brand, Image, Cost, Sales and Speed of Delivery, Exposure, Colleague Recommendations, and Contracts and Incentives. While it was hypothesized that differences among audiologists in the importance ratings of these factors would dictate their preference for a given brand, that was not our finding. Specifically, mean ratings for the six most important factors did not differ among audiologists preferring different brands. A statistically significant difference among audiologists preferring different brands was present, however, for one factor: Contracts and Incentives. Its assigned importance, though, was always lower than that for the other six factors. CONCLUSIONS: Although most audiologists have a preferred hearing aid brand, differences in the perceived importance of common factors attributed to brands do not largely determine preference for a particular brand.

[Audiological evaluation of a child with Klippel-Feil syndrome]. / Klippel-Feil sendromlu bir çocukta odyolojik degerlendirme.

A 6-year-old boy with formerly diagnosed Klippel-Feil syndrome (KFS) presented with complaints of hearing loss, speech disorder, and problems related to his hearing aid. Clinical examination and computed tomography showed bilateral external and middle ear anomalies and audiological examination revealed bilateral severe conductive hearing impairment. The patient was prescribed a bone conduction hearing aid and, with necessary consultations, was examined for additional physical anomalies. All children with a diagnosis of KFS should be evaluated with audiologic and otologic examinations, consultations should be implemented with other disciplines concerning the presenting problems, a regular follow-up should be scheduled, and the parents should be informed on possible complications.

Implantable hearing devices.

PURPOSE OF REVIEW: Implantable hearing devices have been developed to address the shortcomings of traditional hearing aids. Currently, there are two US Food and Drug Administration clinical trials evaluating fully implantable hearing devices. RECENT FINDINGS: Implantable hearing devices attempt to improve upon stigma, cosmesis, occlusion effect, and feedback, as well as other factors that prevent patients from using traditional hearing aids. However, there are many challenges inherent in designing an implantable hearing device. Different devices have attempted to overcome these challenges in different ways. We will discuss these differences in design, their individual pros and cons as well as directions of future research. SUMMARY: Although implantable hearing devices are not currently available they do hold promise for patients not adequately served by conventional hearing aids.