Hearing Aid Enhancements for Hearing Loss
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University Charles River Campus
Disqualifiers: Non-native English speakers, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Hearing Aid Condition, Hearing Aid, Auditory Prosthetic Device, Hearing Instrument for hearing loss?
Research shows that hearing aids significantly improve the ability to understand speech and hear environmental sounds, enhancing the quality of life for those with hearing loss. Studies highlight that users report satisfaction with hearing aid performance in various listening situations, and new technologies continue to improve these outcomes.12345
Is the use of hearing aids and related devices generally safe for humans?
How does the Hearing Aid Condition treatment differ from other treatments for hearing loss?
The Hearing Aid Condition treatment, which involves conventional hearing aids, differs from other treatments like cochlear implants and electromagnetic hearing devices by primarily amplifying sound within the ear canal. Unlike implantable devices that bypass the ear canal and directly stimulate the auditory system, conventional hearing aids can face issues like acoustic feedback and require a tight ear mold, but they are non-invasive and widely accessible.58111213
Eligibility Criteria
This trial is for adults with hearing loss. Young adults (18-35) must have normal hearing levels, while older participants (up to 80) should have sensorineural hearing loss. All must understand English, provide consent, and have normal or corrected vision.Inclusion Criteria
I am 18-35, with normal hearing and vision (with or without correction), and can understand the study.
I am between 18-80 years old with sensorineural hearing loss and can see normally or with correction.
Exclusion Criteria
Non-native speakers of English
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline measurements of interaural time difference discrimination, speech intelligibility, externalization rating, and speech reception threshold are conducted
Up to 4 hours
Intervention
Participants are exposed to various hearing-aid conditions to assess improvements in spatial perception and speech intelligibility
Up to 4 hours
Follow-up
Participants are monitored for any changes in spatial perception and speech intelligibility post-intervention
4 weeks
Treatment Details
Interventions
- Hearing Aid Condition (Behavioural Intervention)
Trial OverviewThe study tests if spatial perception and speech clarity in noisy environments can be improved for hearing aid users through increased high-frequency sounds, speech envelope enhancement, or better sound image externalization.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Experimental conditionExperimental Treatment1 Intervention
Participants will be presented with sound stimuli under a number of experimental conditions that simulate different hearing-aid conditions.
Hearing Aid Condition is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Hearing Aid for:
- Hearing Loss
- Sensorineural Hearing Loss
- Conductive Hearing Loss
🇺🇸 Approved in United States as Hearing Aid for:
- Hearing Loss
- Sensorineural Hearing Loss
- Conductive Hearing Loss
🇨🇦 Approved in Canada as Hearing Aid for:
- Hearing Loss
- Sensorineural Hearing Loss
- Conductive Hearing Loss
🇯🇵 Approved in Japan as Hearing Aid for:
- Hearing Loss
- Sensorineural Hearing Loss
- Conductive Hearing Loss
🇨🇳 Approved in China as Hearing Aid for:
- Hearing Loss
- Sensorineural Hearing Loss
- Conductive Hearing Loss
🇨🇭 Approved in Switzerland as Hearing Aid for:
- Hearing Loss
- Sensorineural Hearing Loss
- Conductive Hearing Loss
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston UniversityBoston, MA
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Who Is Running the Clinical Trial?
Boston University Charles River CampusLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
The successful hearing aid user. [2000]Improvements and modifications in design, construction, evaluation, and application procedures with the wearable hearing aid have brought the benefits of successful hearing aid use to an ever increasing proportion of the hearing impaired population. Many of today's successful hearing aid users would have been regarded at one time as extremely poor risks for hearing aid use. As a consequence, many of the prognostic principles developed as guidelines in advising for or against hearing aid trial are no longer true and should be discarded. Every person who experiences difficulties related to a permanent hearing impairment, no matter how slight or severe hearing loss, should have access to aural rehabilitation, including the use of wearable amplication.
Hearing aid evaluation and fitting. [2012]Although many patients with hearing loss benefit from medical or surgical intervention, the vast majority have noncorrectable hearing disorders for which rehabilitation through amplification is indicated. There are three goals for the application of hearing aids: (1) to amplify normal conversational speech to levels that are maximally understandable to the patient; (2) to help the patient hear other environmental sounds; and (3) to assist in the educational or habilitative process for those children who sustain hearing loss prior to language and speech development. In addition, there are certain issues that require medical consideration when a wearable device is placed in the ear. This article describes current hearing aid technology; reviews its benefits, limitations, and application for typical patients; discusses the medical aspects of hearing aid fitting; and describes new hearing aid technology on the horizon.
Factors associated with hearing aid fitting outcomes on the IOI-HA. [2022]A hallmark of quality clinical practice in audiology should be the ongoing measurement of outcomes in order to improve practice. The aims of this study were to describe outcomes for a large sample of clients fitted with hearing aids and to investigate factors associated with mean IOI-HA scores, with a view to providing guidance about factors that warrant particular attention in the clinic in order to improve outcomes. Measures used were the international outcome inventory - hearing aids (IOI-HA; Cox & Alexander, 2002 ) and a series of questions about satisfaction with hearing aid performance in different listening situations, hearing aid attributes, and clinical service. The participant sample consisted of 1653 adults, most often fitted bilaterally (78%); 81% had digital aids with at least two listening programs. Results of the regression analysis indicated that there were a number of significant factors that, in total, explained 57% of the variance in IOI-HA scores. Higher mean IOI-HA scores were most strongly associated with greater satisfaction with hearing aid attributes of aid fit/comfort, clarity of tone and sound, and comfort with loud sounds and with satisfaction in the listening situations of conversation with one person, in small groups, in large groups, and outdoors. These findings highlight the importance of focusing rehabilitation on improving satisfaction with aided listening across a range of environments and with key attributes of hearing aid performance.
Treatment efficacy: hearing aids in the management of hearing loss in adults. [2018]Hearing impairment in adults is a prevalent chronic condition, associated with psychosocial and quality-of-life handicaps. Recent investigations have demonstrated that individuals with handicapping hearing impairments do indeed benefit from the rehabilitative services offered by audiologists, with the primary intervention being hearing aid provision. My objective here is to review the experimental research, program evaluation data, and case studies documenting the efficacy of hearing aids, with an emphasis on the functional and communicative benefits accruing from hearing aid use. It is hoped that the information contained herein will provide clinicians with outcome data to share with the hearing impaired, toward the goal of encouraging such individuals to take advantage, at least for a trial period, of one of the many technologies available to assist them to function better in their daily lives.
Electromagnetic semi-implantable hearing device: phase I. Clinical trials. [2019]Conventional hearing aids have improved significantly in recent years; however, amplification of sound within the external auditory canal creates a number of intrinsic problems, including acoustic feedback and the need for a tight ear mold to increase usable gain. Nonacoustic alternatives which could obviate these encumbrances have not become practical due to inefficient coupling (piezoelectric techniques) or unfeasible power requirements (electromagnetic techniques). Recent technical advances, however, prompted a major clinical investigation of a new electromagnetic, semi-implantable hearing device. This study presents the details of clinical phase I, in which an electromagnetic driver was coupled with a target magnet temporarily affixed onto the lateral surface of the malleus of six hearing aid users with sensorineural losses. The results indicate that the electromagnetic hearing device provides sufficient gain and output characteristics to benefit individuals with sensorineural hearing loss. Significant improvements compared to conventional hearing aids were noted in pure-tone testing and, to a lesser degree, in speech discrimination. Subjective responses were quite favorable, indicating that the electromagnetic hearing device 1. produces no acoustic feedback; 2. works well in noisy environments; and 3. provides a more quiet, natural sound than patients' conventional hearing aids. These favorable results led to phase II of the project, in which patients with surgically amendable mixed hearing losses were implanted with the target magnet incorporated within a hydroxyapatite ossicular prosthesis. The results of this second-stage investigation were also encouraging and will be reported separately.
Adverse events associated with bone-conduction and middle-ear implants: a systematic review. [2021]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.
A pilot study of the safety and performance of the Otologics fully implantable hearing device: transducing sounds via the round window membrane to the inner ear. [2009]The safety and performance of the Otologics fully implantable hearing device were assessed in adult patients with mixed conductive and sensorineural hearing loss.
Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. [2022]Patients suffering from severe to profound hearing loss or even deafness can achieve a hearing improvement with a cochlear implant (CI) treatment that is significantly higher than the results achieved with conventional hearing aids. The CI system consists of an implantable stimulator, which is inserted retro-auricularly into the mastoid, and an externally worn processor unit, which provides the pickup of sound and processing of acoustic information as well as the power supply for the stimulator and internal current sources. The stimulator has an electrode array that is inserted into the cochlea.
Machine learning for pattern detection in cochlear implant FDA adverse event reports. [2021]Importance: Medical device performance and safety databases can be analyzed for patterns and novel opportunities for improving patient safety and/or device design. Objective: The objective of this analysis was to use supervised machine learning to explore patterns in reported adverse events involving cochlear implants. Design: Adverse event reports for the top three CI manufacturers were acquired for the analysis. Four supervised machine learning algorithms were used to predict which adverse event description pattern corresponded with a specific cochlear implant manufacturer and adverse event type. Setting: U.S. government public database. Participants: Adult and pediatric cochlear patients. Exposure: Surgical placement of a cochlear implant. Main Outcome Measure: Classification prediction accuracy (% correct predictions). Results: Most adverse events involved patient injury (n = 16,736), followed by device malfunction (n = 10,760), and death (n = 16). The random forest, linear SVC, naïve Bayes and logistic algorithms were able to predict the specific CI manufacturer based on the adverse event narrative with an average accuracy of 74.8%, 86.0%, 88.5% and 88.6%, respectively. Conclusions & relevance: Using supervised machine learning algorithms, our classification models were able to predict the CI manufacturer and event type with high accuracy based on patterns in adverse event text descriptions.
Otologics fully implantable hearing system: Phase I trial 1-year results. [2015]To assess the safety of the Otologics fully implantable hearing system after 1 year of use in a Phase I clinical trial.
Spectro-temporal characteristics of speech at high frequencies, and the potential for restoration of audibility to people with mild-to-moderate hearing loss. [2021]It is possible for auditory prostheses to provide amplification for frequencies above 6 kHz. However, most current hearing-aid fitting procedures do not give recommended gains for such high frequencies. This study was intended to provide information that could be useful in quantifying appropriate high-frequency gains, and in establishing the population of hearing-impaired people who might benefit from such amplification.
[Active electronic cochlear implants for middle and inner ear hearing loss--a new era in ear surgery. I: Basic principles and recommendations on nomenclature]. [2019]Hearing aids have fundamental disadvantages: (1) stigmatization of the patient; (2) the sound is often found to be unsatisfactory due to the limited frequency range and undesired distortion; (3) in many patients, the ear canal fitting device generally necessary leads to an occlusion effect; (4) acoustic feedback when amplification is high. Conventional hearing aids transmit sound into the ear canal via a small microphone. Sound has the disadvantage of requiring high output sound pressure levels for its transmission. This along with the necessary miniaturization of the loudspeaker as well as the resonances and reflections in the closed ear canal contribute to the disadvantages mentioned. In contrast, implantable hearing aids do not make sound signals but micromechanical vibrations. An implantable hearing aid has an electromechanical transducer instead of the loudspeaker of a conventional hearing aid. The hearing signal does not leave the transducer as sound but as a mechanical vibration which is directly coupled to the auditory system bypassing the air. This implantable hearing aid is either coupled to the tympanic membrane, the ossicular chain, the perilymph of the inner ear, or the skull. An implantable hearing aid is expected to have: 1 Better sound fidelity than a hearing aid 2 No ear canal fitting device, free ear canal 3 No feedback 4 Invisibility Requirements on electronic hearing implants designed for patients with conductive hearing loss differ from those on implants for sensorineural hearing loss. Conductive hearing loss requires the implant to replace the impedance transformation, thus being an impedance transformation implant (ITI). In various respects, the demands on an ITI are lower than the demands on an electronic hearing aid for patients with sensorineural hearing loss. The latter are mostly patients with a failure of the cochlea amplifier (CA). A damage to the CA is clinically discernible by a positive recruitment and loss of otoacoustic emissions (OAE). Since these patients form the majority of cases with sensorineural hearing loss, an active hearing implant for such patients should partially replace the function of the CA. Therefore, the suggestion is to refer to a CAI (cochlea amplifier implant). The implant expressions ITI (for patients with conductive hearing loss) and CAI (for patients with sensorineural hearing loss) used in this context allow nomenclatural association with the CI (cochlear implant) for complete inner ear failure as well as with the BSI (brainstem implant) in the case of hearing nerve failure.
[Bone Conduction and Active Middle Ear Implants]. [2017]The majority of patients with moderate to severe hearing loss can be supplied with conventional hearing aids depending on severity and cause for hearing loss in a satisfying way. However, some patients either do not benefit enough from conventional hearing aids or cannot wear them due to inflammatory reactions and chronic infections of the external auditory canal or due to anatomical reasons. For these patients there are fully- and semi-implantable middle ear and bone conduction implants available. These devices either directly stimulate the skull (bone conduction devices), middle ear structures (active middle ear implants) or the cochlea itself (direct acoustic stimulation). Patients who failed surgical hearing rehabilitation or do not benefit from conventional hearing aids may achieve a significant better speech understanding and tremendous improvement in quality of life by implantable hearing devices with careful attention to the audiological and anatomical indication criteria.