Hearing LossNCT05782153
Comparing Self-Fitting Strategies in the Lexie Powered by Bose Hearing Aids
A study testing Intervention A (hearing aid self-fitting with direct adjustment) and Intervention B (hearing aid self-fitting with in-situ fitting) in people with Hearing Loss, run by hearX Group at 1 site in South Africa.
Trial summary
More than 1.5 billion people around the world experience hearing loss, of whom at least 430 million experience disabling hearing loss that will require rehabilitation. The majority of people have mild to moderate hearing loss and can benefit from hearing aids. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Intervention A (hearing aid self-fitting with direct adjustment) and Intervention B (hearing aid self-fitting with in-situ fitting)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Africa
- Study dates
- 17 Jul 2023to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (>18 years) living in South Africa
- Good English proficiency (measured using an online English proficiency test as well as self-report of English speaking competence)
- Must have mild-to-moderate self-perceived hearing difficulties
- Possession of a smartphone compatible with the Lexie app (iOS or Android)
- Access to mobile data to operate the Lexie app
- Must have transport to visit the initial and follow-up assessments
Who cannot join
- Normal hearing or self-perceived severe-to-profound hearing loss
- Active outer or middle ear pathology
- Poor English proficiency
- Diagnosed cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Self-Fitting Strategies in the Lexie Powered by Bose Hearing Aids: A Randomized Control Trial
More than 1.5 billion people around the world experience hearing loss, of whom at least 430 million experience disabling hearing loss that will require rehabilitation. The majority of people have mild to moderate hearing loss and can benefit from hearing aids. However, hearing aid adoption around the world has been low, with global hearing aid coverage being less than 11%. This is partly due to limited access to hearing healthcare services and the high cost of hearing devices.
However, there have been significant efforts to improve access to hearing healthcare services. This includes rapid advances in hearing aids and new service-delivery models leading to more affordable and accessible options such as Over-the-Counter (OTC) hearing aids. On the 17th of October 2022, the Food and Drug Administration (FDA) established a regulatory category for OTC hearing aids. The final rule allows consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting by an audiologist. The FDA defined two sub-categories for OTC hearing aids, namely 1) OTC hearing aids with standardized output profiles (i.e., pre-set programs) and 2) self-fitting OTC hearing aids which allow users to program their hearing aids with a self-fitting strategy and also customize their hearing aid settings according to their needs and preferences.
Read more
Sabin et al. (2020) was the first study to validate a self-fitting method using the Bose prototype hearing aid. This self-fitting method allowed users to select their own signal processing parameters using a mobile application consisting of two wheels that simultaneously control the gain and compression of all frequency bands. Sabin et al. (2020) evaluated the real-world performance of this approach by comparing gain, sound quality and clinical measures of hearing aid benefit and satisfaction between a group using the self-fitting method and a group that was professionally fitted with the same hearing aid. The gain selected by the self-fit group was within 1.8 dB overall and 5.6 dB per band compared to the gain selected by the audiologist. Participants in the self-fit group reported better sound quality, and there were no differences in clinical measures of hearing aid benefit or satisfaction.
Although a number of studies have compared self-fitting OTC devices to conventional hearing aids fitted by hearing healthcare professionals, no study has compared different self-fitting strategies in the same OTC device. Therefore, this study aims to compare the existing self-fitting strategy of the Lexie Powered by Bose hearing aids (i.e., direct adjustment) to a recently validated in-situ audiometry fitting strategy. The in-situ audiometry fitting strategy consists of in-situ thresholds measurements conducted at 500, 1000, 2000 and 4000 Hz through the hearing aids, which will be used with a proprietary fitting algorithm that is based on National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2) to self-program the hearing aids.
Read the detailed description
- Objective: To compare an in-situ audiometry self-fitting strategy to the Bose self-fitting strategy (i.e., direct adjustment) using the same Lexie B2 Powered by Bose hearing aids. Hearing aid benefit and satisfaction will be compared in the same participants between the two fitting strategies. Additionally, Real Ear Measurements (REM) and speech perception will be compared in the same participants between the two fitting strategies.
- Hypothesis: The investigators hypothesize that there will be no statistically significant difference in terms of perceived hearing aid benefit and satisfaction, REM and speech perception within the same individual after receiving intervention A (hearing aid self-fitting with direct adjustment) and intervention B (hearing aid self-fitting with in-situ fitting) in a randomized, double-blind, cross-over within-subjects controlled trial.
- Design: Randomized, double-blind, cross-over within-subject controlled trial comparing an in-situ audiometry self-fitting strategy to the Bose self-fitting strategy (i.e., direct adjustment) using the same Lexie B2 Powered by Bose hearing aids in the same participants, which allows for participants to be their own control (n=40).
- Setting: This study will involve clinical audiometric testing at the Department of Speech-Language Pathology and Audiology, University of Pretoria, as well as a user field trial of the fitted hearing aids using each fitting strategy.
- Participants: Eligible participants will include 40 adults (>18 years) with a self-perceived mild-to-moderate level of hearing loss, without symptoms of outer- and middle ear pathology and who own a smartphone with access to mobile data (Android or iOS). Participants will be recruited and will randomly be assigned to a group using computer-generated randomization by an independent research assistant after being stratified for sex and degree of hearing loss.
- Intervention: Forty participants will randomly be assigned to be fitted with intervention A (hearing aid self-fitting with direct adjustment) or intervention B (hearing aid self-fitting with in-situ fitting) and wear the hearing aids for four weeks. After four weeks, they will be crossed over to be fitted with the alternative fitting strategy, and they will wear the hearing aids again for four weeks.
- Outcome measures: The primary outcome measure will be the Abbreviated Profile of Hearing Aid Benefit (APHAB). The secondary outcome measures will be the International Outcome Inventory for Hearing Aids (IOI-HA), Overall experience rating, REM, the QuickSIN speech-in-noise test and the Digits-in-noise test.
- Conditions
- Hearing Loss
- Being tested
- Intervention A (hearing aid self-fitting with direct adjustment), Intervention B (hearing aid self-fitting with in-situ fitting)
- Keywords
- hearing loss, hearing aid, hearing rehabilitation, self-fitting hearing aid
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention A (hearing aid self-fitting with direct adjustment)Device
The intervention offered is a hearing aid fitting with the Lexie B2 Powered by Bose receiver-in-the-canal hearing aids using a self-fitting strategy with direct adjustment. The hearing aids will be accompanied and operated with the Lexie smartphone application. Participants will complete a hearing screening (at 500, 1000, 2000 and 4000 Hz) called Hearing Check on the Lexie smartphone application, which will be used to tune the hearing aids according to frequency and loudness level. Participants will be able to use two wheels to change the loudness and fine-tune the hearing aids. Participants will wear the hearing aids for four weeks.
Intervention B (hearing aid self-fitting with in-situ fitting)Device
The intervention offered is a hearing aid fitting with the Lexie B2 Powered by Bose receiver-in-the-canal hearing aids using the in-situ audiometry fitting strategy. The hearing aids will be accompanied and operated with the Lexie smartphone application. Participants will complete an in-situ audiogram on the Lexie app, which enables the measurement of hearing thresholds through the hearing aids (at 500, 1000, 2000 and 4000 Hz). The hearing aids will then be self-programmed according to the participant's in-situ audiogram with a proprietary fitting algorithm that is based on NAL-NL2. Participants will wear the hearing aids for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention A (hearing aid self-fitting with direct adjustment) | Active comparator | Not described Receives: Device: Intervention A (hearing aid self-fitting with direct adjustment) |
| Intervention B (hearing aid self-fitting with in-situ fitting) | Active comparator | Not described Receives: Device: Intervention B (hearing aid self-fitting with in-situ fitting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Abbreviated Profile of Hearing Aid Benefit (APHAB)
APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they experience hearing and communicating in noise in different everyday listening environments. The benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).
Measured: Baseline; After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
Secondary outcomes (5)
International Outcome Inventory for Hearing Aids (IOI-HA)
IOI HA is a seven-item questionnaire designed to evaluate the effectiveness of hearing aid treatment. The responses of the items are assigned a value of 1 to 5, with higher scores indicating a more favourable outcome.
Measured: After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
Overall experience rating
In this questionnaire, participants will be asked about their overall experience with the hearing aid fitting and to rate how easy the process was using a Likert scale.
Measured: After first fitting; after second fitting
Change from baseline QuickSIN speech in noise test
The QuickSIN measures a person's ability to accurately hear speech in noise by determining a signal-to-noise ratio loss. A list of six sentences with five keywords per sentence is presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult). The SNRs used are 25, 20, 15, 10, 5 and 0, encompassing normal to severely impaired performance in noise.
Measured: Baseline; After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
Change from baseline Digits-in-noise test (DIN)
The DIN measure primarily the auditory, or bottom-up, speech recognition abilities in noise. The test determines a speech reception threshold by presenting spoken digit triplets (e.g., 3-4-7) in speech-weighted background masking noise. Twenty-three digits are presented adaptively at different signal-to-noise ratios, based on correct or incorrect recognition of the digits. The speech reception threshold is determined by averaging the signal-to-noise ratios of the last 19-digit triplets.
Measured: Baseline; After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
Change from baseline Real-ear Measurements (REMs)
REM involves placing a fine probe microphone into the ear canal to measure the sound at the eardrum. The hearing aid will be inserted in the ear alongside the probe microphone to measure the amplification effect within the patient's ear, taking into account the patient's ear acoustics.
Measured: Baseline; Before and after 4 weeks of field use with the first intervention; before and after 4 weeks of field use with the second intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start17 Jul 2023
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over within-subjects design. Forty participants will randomly be assigned to do a hearing aid self-fitting with direct adjustment (Intervention A) or a hearing aid self-fitting with in-situ audiometry (Intervention B) using the Lexie Powered by Bose hearing aids and will be asked to wear the hearing aids for four weeks. After four weeks, they will be crossed over to be fitted with the alternative fitting strategy, and they will be asked to wear the hearing aids again for four weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- hearX Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, De Wet Swanepoel, hearX Group
- Investigators
- De Wet Swanepoel, Principal investigator, Department of Speech-Language Pathology and Audiology, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782153
- Sponsor's protocol ID
- LexieB2PoweredbyBose
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bisgaard N, Zimmer S, Laureyns M, Groth J. A model for estimating hearing aid coverage world-wide using historical data on hearing aid sales. Int J Audiol. 2022 Oct;61(10):841-849. doi: 10.1080/14992027.2021.1962551. Epub 2021 Aug 24.
PubMed 34428121Committee on Accessible and Affordable Hearing Health Care for Adults; Board on Health Sciences Policy; Health and Medicine Division; National Academies of Sciences, Engineering, and Medicine; Blazer DG, Domnitz S, Liverman CT, editors. Hearing Health Care for Adults: Priorities for Improving Access and Affordability. Washington (DC): National Academies Press (US); 2016 Sep 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK367633/
PubMed 27280276De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):522-530. doi: 10.1001/jamaoto.2023.0376.
PubMed 37052929Ferguson MA, Kitterick PT, Chong LY, Edmondson-Jones M, Barker F, Hoare DJ. Hearing aids for mild to moderate hearing loss in adults. Cochrane Database Syst Rev. 2017 Sep 25;9(9):CD012023. doi: 10.1002/14651858.CD012023.pub2.
PubMed 28944461Food and Drug Administration. (2021). Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. https://www.govinfo.gov/content/pkg/FR-2021-10-20/pdf/2021-22473.pdf
Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111.
PubMed 28252160Keidser G, Convery E. Outcomes With a Self-Fitting Hearing Aid. Trends Hear. 2018 Jan-Dec;22:2331216518768958. doi: 10.1177/2331216518768958.
PubMed 29716438Manchaiah V, Taylor B, Dockens AL, Tran NR, Lane K, Castle M, Grover V. Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. Clin Interv Aging. 2017 May 18;12:859-871. doi: 10.2147/CIA.S135390. eCollection 2017.
PubMed 28553093Sabin AT, Van Tasell DJ, Rabinowitz B, Dhar S. Validation of a Self-Fitting Method for Over-the-Counter Hearing Aids. Trends Hear. 2020 Jan-Dec;24:2331216519900589. doi: 10.1177/2331216519900589.
PubMed 32003285Swanepoel W, Oosthuizen I, Graham MA, Manchaiah V. Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. Am J Audiol. 2023 Jun;32(2):314-322. doi: 10.1044/2022_AJA-22-00130. Epub 2023 Mar 6.
PubMed 36876936World Health Organization. (2021). World report on hearing. Retrieved from https://www.who.int/publications/i/item/world-report-on-hearing
Knoetze M, Manchaiah V, De Sousa K, Moore DR, Swanepoel W. Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):784-791. doi: 10.1001/jamaoto.2024.2007.
PubMed 39052241
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Self-Fitting Strategies in the Lexie Powered by Bose Hearing Aids: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05782153
- Acronym / sponsor ID
- LexieB2PoweredbyBose
- Conditions
- Hearing Loss
- Keywords
- hearing loss, hearing aid, hearing rehabilitation, self-fitting hearing aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- hearX GroupIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 1.5 billion people around the world experience hearing loss, of whom at least 430 million experience disabling hearing loss that will require rehabilitation. The majority of people have mild to moderate hearing loss and can benefit from hearing aids. However, hearing aid adoption around the world has been low, with global hearing aid coverage being less than 11%. This is partly due to limited access to hearing healthcare services and the high cost of hearing devices.
However, there have been significant efforts to improve access to hearing healthcare services. This includes rapid advances in hearing aids and new service-delivery models leading to more affordable and accessible options such as Over-the-Counter (OTC) hearing aids. On the 17th of October 2022, the Food and Drug Administration (FDA) established a regulatory category for OTC hearing aids. The final rule allows consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting by an audiologist. The FDA defined two sub-categories for OTC hearing aids, namely 1) OTC hearing aids with standardized output profiles (i.e., pre-set programs) and 2) self-fitting OTC hearing aids which allow users to program their hearing aids with a self-fitting strategy and also customize their hearing aid settings according to their needs and preferences.
Sabin et al. (2020) was the first study to validate a self-fitting method using the Bose prototype hearing aid. This self-fitting method allowed users to select their own signal processing parameters using a mobile application consisting of two wheels that simultaneously control the gain and compression of all frequency bands. Sabin et al. (2020) evaluated the real-world performance of this approach by comparing gain, sound quality and clinical measures of hearing aid benefit and satisfaction between a group using the self-fitting method and a group that was professionally fitted with the same hearing aid. The gain selected by the self-fit group was within 1.8 dB overall and 5.6 dB per band compared to the gain selected by the audiologist. Participants in the self-fit group reported better sound quality, and there were no differences in clinical measures of hearing aid benefit or satisfaction.
Although a number of studies have compared self-fitting OTC devices to conventional hearing aids fitted by hearing healthcare professionals, no study has compared different self-fitting strategies in the same OTC device. Therefore, this study aims to compare the existing self-fitting strategy of the Lexie Powered by Bose hearing aids (i.e., direct adjustment) to a recently validated in-situ audiometry fitting strategy. The in-situ audiometry fitting strategy consists of in-situ thresholds measurements conducted at 500, 1000, 2000 and 4000 Hz through the hearing aids, which will be used with a proprietary fitting algorithm that is based on National Acoustics Laboratories' Non-Linear Version 2 (NAL-NL2) to self-program the hearing aids.
Detailed description
- Objective: To compare an in-situ audiometry self-fitting strategy to the Bose self-fitting strategy (i.e., direct adjustment) using the same Lexie B2 Powered by Bose hearing aids. Hearing aid benefit and satisfaction will be compared in the same participants between the two fitting strategies. Additionally, Real Ear Measurements (REM) and speech perception will be compared in the same participants between the two fitting strategies.
- Hypothesis: The investigators hypothesize that there will be no statistically significant difference in terms of perceived hearing aid benefit and satisfaction, REM and speech perception within the same individual after receiving intervention A (hearing aid self-fitting with direct adjustment) and intervention B (hearing aid self-fitting with in-situ fitting) in a randomized, double-blind, cross-over within-subjects controlled trial.
- Design: Randomized, double-blind, cross-over within-subject controlled trial comparing an in-situ audiometry self-fitting strategy to the Bose self-fitting strategy (i.e., direct adjustment) using the same Lexie B2 Powered by Bose hearing aids in the same participants, which allows for participants to be their own control (n=40).
- Setting: This study will involve clinical audiometric testing at the Department of Speech-Language Pathology and Audiology, University of Pretoria, as well as a user field trial of the fitted hearing aids using each fitting strategy.
- Participants: Eligible participants will include 40 adults (>18 years) with a self-perceived mild-to-moderate level of hearing loss, without symptoms of outer- and middle ear pathology and who own a smartphone with access to mobile data (Android or iOS). Participants will be recruited and will randomly be assigned to a group using computer-generated randomization by an independent research assistant after being stratified for sex and degree of hearing loss.
- Intervention: Forty participants will randomly be assigned to be fitted with intervention A (hearing aid self-fitting with direct adjustment) or intervention B (hearing aid self-fitting with in-situ fitting) and wear the hearing aids for four weeks. After four weeks, they will be crossed over to be fitted with the alternative fitting strategy, and they will wear the hearing aids again for four weeks.
- Outcome measures: The primary outcome measure will be the Abbreviated Profile of Hearing Aid Benefit (APHAB). The secondary outcome measures will be the International Outcome Inventory for Hearing Aids (IOI-HA), Overall experience rating, REM, the QuickSIN speech-in-noise test and the Digits-in-noise test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Cross-over within-subjects design. Forty participants will randomly be assigned to do a hearing aid self-fitting with direct adjustment (Intervention A) or a hearing aid self-fitting with in-situ audiometry (Intervention B) using the Lexie Powered by Bose hearing aids and will be asked to wear the hearing aids for four weeks. After four weeks, they will be crossed over to be fitted with the alternative fitting strategy, and they will be asked to wear the hearing aids again for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention A (hearing aid self-fitting with direct adjustment) | Active comparator | Device: Intervention A (hearing aid self-fitting with direct adjustment) |
| Intervention B (hearing aid self-fitting with in-situ fitting) | Active comparator | Device: Intervention B (hearing aid self-fitting with in-situ fitting) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (>18 years) living in South Africa
- Good English proficiency (measured using an online English proficiency test as well as self-report of English speaking competence)
- Must have mild-to-moderate self-perceived hearing difficulties
- Possession of a smartphone compatible with the Lexie app (iOS or Android)
- Access to mobile data to operate the Lexie app
Key exclusion criteria (4 listed)
- Normal hearing or self-perceived severe-to-profound hearing loss
- Active outer or middle ear pathology
- Poor English proficiency
- Diagnosed cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention A (hearing aid self-fitting with direct adjustment)The intervention offered is a hearing aid fitting with the Lexie B2 Powered by Bose receiver-in-the-canal hearing aids using a self-fitting strategy with direct adjustment. The hearing aids will be accompanied and operated with the Lexie smartphone application. Participants will complete a hearing screening (at 500, 1000, 2000 and 4000 Hz) called Hearing Check on the Lexie smartphone application, which will be used to tune the hearing aids according to frequency and loudness level. Participants will be able to use two wheels to change the loudness and fine-tune the hearing aids. Participants will wear the hearing aids for four weeks. | Device | Intervention A (hearing aid self-fitting with direct adjustment) |
| Intervention B (hearing aid self-fitting with in-situ fitting)The intervention offered is a hearing aid fitting with the Lexie B2 Powered by Bose receiver-in-the-canal hearing aids using the in-situ audiometry fitting strategy. The hearing aids will be accompanied and operated with the Lexie smartphone application. Participants will complete an in-situ audiogram on the Lexie app, which enables the measurement of hearing thresholds through the hearing aids (at 500, 1000, 2000 and 4000 Hz). The hearing aids will then be self-programmed according to the participant's in-situ audiogram with a proprietary fitting algorithm that is based on NAL-NL2. Participants will wear the hearing aids for four weeks. | Device | Intervention B (hearing aid self-fitting with in-situ fitting) |
Primary outcome
Change from baseline Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Baseline; After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they experience hearing and communicating in noise in different everyday listening environments. The benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).
5 secondary outcomes
International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
Overall experience rating
Time frame: After first fitting; after second fitting
Change from baseline QuickSIN speech in noise test
Time frame: Baseline; After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
Change from baseline Digits-in-noise test (DIN)
Time frame: Baseline; After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention
Change from baseline Real-ear Measurements (REMs)
Time frame: Baseline; Before and after 4 weeks of field use with the first intervention; before and after 4 weeks of field use with the second intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 34428121Bisgaard N, Zimmer S, Laureyns M, Groth J. A model for estimating hearing aid coverage world-wide using historical data on hearing aid sales. Int J Audiol. 2022 Oct;61(10):841-849. doi: 10.1080/14992027.2021.1962551. Epub 2021 Aug 24.
- Background: PubMed 27280276Committee on Accessible and Affordable Hearing Health Care for Adults; Board on Health Sciences Policy; Health and Medicine Division; National Academies of Sciences, Engineering, and Medicine; Blazer DG, Domnitz S, Liverman CT, editors. Hearing Health Care for Adults: Priorities for Improving Access and Affordability. Washington (DC): National Academies Press (US); 2016 Sep 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK367633/
- Background: PubMed 37052929De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):522-530. doi: 10.1001/jamaoto.2023.0376.
- Background: PubMed 28944461Ferguson MA, Kitterick PT, Chong LY, Edmondson-Jones M, Barker F, Hoare DJ. Hearing aids for mild to moderate hearing loss in adults. Cochrane Database Syst Rev. 2017 Sep 25;9(9):CD012023. doi: 10.1002/14651858.CD012023.pub2.
- BackgroundFood and Drug Administration. (2021). Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. https://www.govinfo.gov/content/pkg/FR-2021-10-20/pdf/2021-22473.pdf
- Background: PubMed 28252160Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111.
- Background: PubMed 29716438Keidser G, Convery E. Outcomes With a Self-Fitting Hearing Aid. Trends Hear. 2018 Jan-Dec;22:2331216518768958. doi: 10.1177/2331216518768958.
- Background: PubMed 28553093Manchaiah V, Taylor B, Dockens AL, Tran NR, Lane K, Castle M, Grover V. Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. Clin Interv Aging. 2017 May 18;12:859-871. doi: 10.2147/CIA.S135390. eCollection 2017.
- Background: PubMed 32003285Sabin AT, Van Tasell DJ, Rabinowitz B, Dhar S. Validation of a Self-Fitting Method for Over-the-Counter Hearing Aids. Trends Hear. 2020 Jan-Dec;24:2331216519900589. doi: 10.1177/2331216519900589.
- Background: PubMed 36876936Swanepoel W, Oosthuizen I, Graham MA, Manchaiah V. Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. Am J Audiol. 2023 Jun;32(2):314-322. doi: 10.1044/2022_AJA-22-00130. Epub 2023 Mar 6.
- BackgroundWorld Health Organization. (2021). World report on hearing. Retrieved from https://www.who.int/publications/i/item/world-report-on-hearing
- Derived from this study: PubMed 39052241Knoetze M, Manchaiah V, De Sousa K, Moore DR, Swanepoel W. Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):784-791. doi: 10.1001/jamaoto.2024.2007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
De Wet Swanepoel principal investigator
Department of Speech-Language Pathology and Audiology, University of Pretoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention A (hearing aid self-fitting with direct adjustment) and Intervention B (hearing aid self-fitting with in-situ fitting) in people with Hearing Loss, run by hearX Group at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: Baseline; After 4 weeks of field use with the first intervention; after 4 weeks of field use with the second intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782153, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.